biotechnology dissertation project

ICMR - NIRT is a permanent Institute under the Indian Council of Medical Research (ICMR) and an internationally recognized institution for research in Tuberculosis (TB) and associated co-morbidities including HIV and Diabetes Mellitus. The Institute is equipped with state-of-the-art research facilities. It is a Supranational Reference Laboratory and a WHO Collaborating Centre for TB Research and Training. An International Centre for Excellence in Research (ICER) in collaboration with NIH is functioning at the Institute.

Highly motivated individuals with good academic credentials and a keen desire to pursue research in frontier areas of Infectious Disease on tuberculosis are invited to apply for an Internship/Dissertation at ICMR - National Institute for Research in Tuberculosis [ICMR - NIRT].

Who can apply?

Individuals studying any of the courses below from State/Central Government/MCI/AICTE/UGC - recognized University/ College/Institute.

Duration of Internship/Dissertation Programme:
The dissertation programme will be allowed for a minimum period of 6 months.  Internship/Observation visit is permitted for a period of 15 days.

Application Procedure:
Interested candidates may apply by filling the online application at the ICMR-NIRT website. The application link will be opened on 15th January/15th April/15th July/15th October and the applications will be received for 7 days from the date of opening.

 
The candidates will be selected based on their application and availability of supervisors. The decision of the Director will be final and no further correspondence will be entertained in this regard.

The names of selected candidates will be published on the ICMR-NIRT website. The selected candidates should contact the Heads of the respective Departments for further course of action .

General Instructions: 1. ICMR-NIRT will consider only the applications with complete information.

2. A requisition letter with a photo of the individual from the Head of the Institution is required.

3. In case of dissertation work, a concept paper is mandatory to be uploaded during the application

4. Selected candidates should strictly adhere to the rules and regulations of the Institute.

5. Selected candidates will work under the direct supervision of the Scientist/ Faculty nominated by the Director, ICMR - NIRT.

6. Selected candidates should pay the fees towards their internship/dissertation as soon as they join in their respective departments.

7. Upon successful completion of the assigned work, the candidates will receive a completion Certificate from the Supervisor and the Director, ICMR – NIRT.

8. In case of dissertation work, submission of a copy of the completed thesis is required.

9.   Selected candidates are bound to respect the confidentiality of information that they collect or are exposed to at ICMR-NIRT. No reports or papers may be published based on information obtained from ICMR-NIRT without the explicit written authorization of the Supervisor and the Director, ICMR-NIRT.

10. Although not considered a staff member of ICMR-NIRT, selected candidates shall follow the rules and regulations of ICMR-NIRT. The candidates will not be entitled to the privileges accorded to the officials and staff members of ICMR-NIRT.

11. Candidates should make their arrangements for accommodation, travel and living expenses. ICMR - NIRT WILL NOT arrange for the same.

12. The ICMR-NIRT Internship/Dissertation Programme does not entail any form of employment in the institute

13. ICMR-NIRT accepts no responsibility for costs or fatality arising from illness or accidents incurred during the internship/dissertation; therefore, candidates must carry adequate responsibilities of their medical conditions.

14. For any queries, please write to [email protected]

Instructions for filling the online application: 1. Passport size photo and signature should be uploaded in image format 2. Requisition, Resume and Concept paper (if applicable) should be uploaded in pdf format 3. All supporting documents uploaded should be of size <1 MB

Top 50 Research Topics in Biotechnology

Table of Contents

Biotechnology

Research in biotechnology can helps in bringing massive changes in humankind and lead to a better life. In the last few years, there have been so many leaps, and paces of innovations as scientists worldwide worked to develop and produce novel mRNA vaccinations and brought some significant developments in biotechnology. During this period, they also faced many challenges. Disturbances in the supply chain and the pandemic significantly impacted biotech labs and researchers, forcing lab managers to become ingenious in buying lab supplies, planning experiments, and using technology for maintaining research schedules.

The Biotech Research Technique is changing

How research is being done is changing, as also how scientists are conducting it. Affected by both B2C eCommerce and growing independence in remote and cloud-dependent working, most of the biotechnology labs are going through some digital transformations. This implies more software, automation, and AI in the biotech lab, along with some latest digital procurement plans and integrated systems for various lab operations.

Look at some of the top trends in biotech research and recent Biotechnology Topics that are bringing massive changes in this vast world of science, resulting in some innovation in life sciences and biotechnology ideas .

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Research Proposal Topics In Biotechnology

Biotechnology is a fascinating subject that blends biology and technology and provides a huge chance to develop new ideas. However, before pursuing a career in this field, a person needs to complete a number of studies and have a thorough knowledge of the matter. When we begin our career must we conduct study to discover some innovative innovations that could benefit people around the world. Biotechnology is one of a variety of sciences of life, including pharmacy. Students who are pursuing graduation, post-graduation or PhD must complete the research work and compose their thesis to earn the satisfaction in their education. When choosing a subject for biotechnology-related research it is important to choose one that is likely to inspire us. Based on our passion and personal preferences, the subject to study may differ.

What is Biotechnology?

In its most basic sense, biotechnology is the science of biology that enables technology Biotechnology harnesses the power of the biomolecular and cellular processes to create products and technologies that enhance our lives and the wellbeing of the planet. Biotechnology has been utilizing microorganisms' biological processes for over six thousand years to create useful food items like cheese and bread as well as to keep dairy products in good condition.

Modern biotechnology has created breakthrough products and technology to treat rare and debilitating illnesses help reduce our footprint on the environment and feed hungry people, consume less energy and use less and provide safer, more clean and productive industrial production processes.

Introduction

Biotechnology is credited with groundbreaking advancements in technological development and development of products to create sustainable and cleaner world. This is in large part due to biotechnology that we've made progress toward the creation of more efficient industrial manufacturing bases. Additionally, it assists in the creation of greener energy, feeding more hungry people and not leaving a large environmental footprint, and helping humanity fight rare and fatal diseases.

Our writing services for assignments within the field of biotechnology covers all kinds of subjects that are designed to test and validate the skills of students prior to awarding their certificates. We assist students to successfully complete their course in all kinds of biotechnology-related courses. This includes biological sciences for medical use (red) and eco-biotechnology (green) marine biotechnology (blue) and industrial biotechnology (white).

What do we hope to gain from all these Initiatives?

Our primary goal in preparing this list of the top 100 biotechnology assignment subjects is to aid students in deciding on effective time management techniques. We've witnessed a large amount of cases where when looking for online help with assignments with the topic, examining sources of information, and citing the correct order of reference students find themselves stuck at various points. In the majority of cases, students have difficulty even to get through their dilemma of choosing a topic. This is why we contribute in our effort to help make the process easier for students in biotech quickly and efficiently. Our students are able to save time and energy in order to help them make use of the time they are given to write the assignment with the most appropriate topics.

Let's look at some of the newest areas of biotechnology research and the related areas.

• Renewable Energy Technology Management Promoting Village
• Molasses is a molasses-based ingredient that can be used to produce and the treatment of its effluent
• Different ways to evapotranspirate
• Scattering Parameters of Circulator Bio-Technology
• Renewable Energy Technology Management Promoting Village.

Structural Biology of Infectious Diseases

A variety of studies are being conducted into the techniques used by pathogens in order to infect humans and other species and for designing strategies for countering the disease. The main areas that are available to study by biotech researchers include:

• inlA from Listeria monocytogenes when combined with E-cadherin from humans.
• InlC in Listeria monocytogenes that are multipart with human Tuba.
• Phospholipase PatA of Legionella pnemophila.
• The inactivation process of mammalian TLR2 by inhibiting antibody.
• There are many proteins that come originate from Mycobacterium tuberculosis.

Plant Biotechnology

Another significant area for research in biotechnology for plants is to study the genetic causes of the plant's responses to scarcity and salinity, which have a significant impact on yields of the crop and food.

• Recognition and classification of genes that influence the responses of plants to drought and salinity.
• A component of small-signing molecules in plants' responses to salinity and drought.
• Genetic enhancement of plant sensitivity salinity and drought.

Pharmacogenetics

It's also a significant area for conducting research in biotechnology. One of the most important reasons for doing so could be the identification of various genetic factors that cause differences in drug effectiveness and susceptibility for adverse reactions. Some of the subjects which can be studied are,

• Pharmacogenomics of Drug Transporters
• Pharmacogenomics of Metformin's response to type II mellitus
• The pharmacogenomics behind anti-hypertensive medicines
• The Pharmacogenomics of anti-cancer drugs

Forensic DNA

A further area of research in biotechnology research is the study of the genetic diversity of humans for its applications in criminal justice. Some of the topics that could be studied include,

• Y-chromosome Forensic Kit, Development of commercial prototype.
• Genetic testing of Indels in African populations.
• The Y-chromosome genotyping process is used for African populations.
• Study of paternal and maternal ancestry of mixed communities in South Africa.
• The study of the local diversity in genetics using highly mutating Y-STRs and Indels.
• South African Innocence Project: The study of DNA extracted from historical crime scene.
• Nanotechnology is a new technology that can be applied to DNA genotyping.
• Nanotechnology methods to isolate DNA.

Food Biotechnology

It is possible to conduct research in order to create innovative methods and processes in the fields of food processing and water. The most fascinating topics include:

• A molecular-based technology that allows for the rapid identification and detection of foodborne pathogens in intricate food chains.
• The effects of conventional and modern processing techniques on the bacteria that are associated with Aspalathus lineriasis.
• DNA-based identification of species of animals that are present in meat products that are sold raw.
• The phage assay and PCR are used to detect and limit the spread of foodborne pathogens.
• Retention and elimination of pathogenic, heat-resistant and other microorganisms that are treated by UV-C.
• Analysis of an F1 generation of the cross Bon Rouge x Packham's Triumph by Simple Sequence Repeat (SSR/microsatellite).
• The identification of heavy metal tolerant and sensitive genotypes
• Identification of genes that are involved in tolerance to heavy metals
• The isolation of novel growth-promoting bacteria that can help crops cope with heavy metal stress . Identification of proteins that signal lipids to increase the tolerance of plants to stress from heavy metals

This topic includes high-resolution protein expression profiling for the investigation of proteome profiles. The following are a few of the most fascinating topics:

• The identification and profile of stress-responsive proteins that respond to abiotic stress in Arabidopsis Thalian and Sorghum bicolor.
• Analyzing sugar biosynthesis-related proteins in Sorghum bicolor, and study of their roles in drought stress tolerance
• Evaluation of the viability and long-term sustainability of Sweet Sorghum for bioethanol (and other by-products) production in South Africa
• In the direction of developing an environmentally sustainable, low-tech hypoallergenic latex Agroprocessing System designed specifically especially for South African small-holder farmers.

Bioinformatics

This is an additional aspect of biotechnology research. The current trend is to discover new methods to combat cancer. Bioinformatics may help identify proteins and genes as well as their role in the fight against cancer. Check out some of the areas that are suitable to study.

• Prediction of anticancer peptides with HIMMER and the the support vector machine.
• The identification and verification of innovative therapeutic antimicrobial peptides for Human Immunodeficiency Virus In the lab and molecular method.
• The identification of biomarkers that are associated with cancer of the ovary using an molecular and in-silico method.
• Biomarkers identified in breast cancer, as possible therapeutic and diagnostic agents with a combination of molecular and in-silico approaches.
• The identification of MiRNA's as biomarkers for screening of cancerous prostates in the early stages an in-silico and molecular method
• Identification of putatively identified the genes present in breast cancer tissues as biomarkers for early detection of lobular and ductal breast cancers.
• Examining the significance of Retinoblastoma Binding Protein 6 (RBBP6) in the regulation of the cancer-related protein Y-Box Binding Protein 1 (YB-1).
• Examining the role played by Retinoblastoma Binding Protein 6 (RBBP6) in the regulation of the cancer suppressor p53 through Mouse Double Minute 2 (MDM2).
• Structural analysis of the anti-oxidant properties of the 1-Cys peroxiredoxin Prx2 found in the plant that resurrects itself Xerophyta viscosa.

Nanotechnology

This is a fascinating aspect of biotechnology, which can be used to identify effective tools to address the most serious health issues.

• Evaluation of cancer-specific peptides to determine their applications for the detection of cancer.
• The development of a quantum dot-based detection systems for breast cancer.
• The creation of targeted Nano-constructs for in vivo imaging as well as the treatment of tumors.
• Novel quinone compounds are being tested as anti-cancer medicines.
• Embedelin is delivered to malignant cells in a specific manner.
• The anti-cancer activities of Tulbaghia Violacea extracts were studied biochemically .
• Novel organic compounds are screened for their anti-cancer potential.
• To treat HIV, nanotechnology-based therapeutic techniques are being developed.

Top 100 Biotechnology Research Proposal Topics to Consider in 2022

We've prepared a list of the top 100 most suggested dissertation topics, which were compiled by our experts in research. They've made sure to offer a an extensive list of topics that cover all aspects of the topic. We hope that this list will meet all of the requirements for assistance with your dissertation . Let us start with our list of subjects, one at a time each one

• Achieving effective control of renewable power technologies to help the village
• The production of ethanol through the aid of molasses and the treatment of its effluent
• Different approaches and aspects of Evapotranspiration
• Its scattering parameter is biotechnology circulator
• The inactivation of mammalian TLR2 via an inhibiting antibody
• The number of proteins produced by Mycobacterium tuberculosis
• Recognition and classification of genes that shape the responses of plants to drought and salinity.
• The small sign molecules that are involved in the response that plants have to the effects of salinity as well as drought
• Genetic improvement of the plant's sensitivity to drought and saltiness
• The pharmacogenomics of drug transporters
• The anti-cancer drugs' pharmacogenomics are based on pharmac
• The pharmacogenomics of antihypertensive medications
• Indels genotyping of African populations
• Genomics of the Y-chromosomes of African populations
• The profiling of DNA extracted from historical crime scenes Consider the implications of South African Innocence Project
• Nanotechnology-related methods for DNA isolation
• Nanotechnology applications in the context of DNA genotyping
• Recognizing the heavy metals that are tolerant with genotypes that are sensitive.
• Genetic characteristics that play a role within the procedure of gaining tolerance to metals
• The animal's DNA is authenticated by the species by the commercial production of raw meat products
• The use of molecular-based technology is in the sense of detection and identification of foodborne pathogens in complicated food systems
• Assessing the effectiveness of cancer-specific peptides that are suitable for efficient implementations in the area of diagnosis and treatment for cancer
• Quantum Dot-based detection system is being developed in relation to a positive breast cancer diagnosis
• It is targeted delivery of the embelin to cancerous cells
• Exploring the potential of novel quinone compounds as anti-cancer agents
• Treatment strategies for treating HIV in addition to the significance of nanotechnology the treatment of HIV.
• A review of the medicinal value the antioxidants found in nature.
• An in-depth examination of the structure of COVID spike proteins
• A review of the immune response to the stem therapy using cells
• CRISPR-Cas9 technology to aid in the process of editing the genome
• Tissue engineering and delivery of drugs through the application of Chitosan
• Evaluation of beneficial effects of cancer vaccines
• Use of PacBio sequencing in relation to genome assembly of model organisms
• Examining the connection between mRNA suppression and its effect on the growth of stem cells
• Biomimicry is a method of identifying of cancer cells
• The sub-classification and characterisation of the Yellow enzymes
• The process of producing food products that are hypoallergenic and fermented.
• The production of hypoallergenic milk
• The purification process for the thermostable phytase
• Bioconversion of the cellulose produce products that are significant for industry
• The investigation of the gut microbiota of the model organisms
• The use of fungal enzymes for the manufacture of chemical glue
• A look at those inhibitors to exocellulase as well as endocellulase
• Examine the value of microorganisms to aid in the recovery of gas from shale.
• Examine the thorough analysis of the method of natural decomposition
• Examine ways to recycle bio-wastes
• Improved bio-remediation in the case of oil spills
• The process of gold biosorption is accomplished with the aid of the cyanobacterium
• A healthy equilibrium between the biotic and the abiotic elements by using biotechnological devices
• The measurement of the mercury level in fish by means of markers
• Exploring the biotechnological capabilities from Jellyfish related microbiomes Jellyfish related microbiome
• What is the role of marine fungi to aid in attempts to break down plastics and polymers?
• Examine the biotechnological possibilities that can be extracted of dinoflagellates
• Removing endosulfan residues using the use of biotechnology the agriculture sector
• The creation of the ELISA method for the detection of crop virus
• Enhancing the quality of drinking water by the aid of the E.coli consortium
• The characterisation of E.coli is its isolation from the feces of Zoo animals
• Enhancing the resistance of crops to the attack of insects
• The reduction of the expenditure on agriculture by using efficient bio-tools
• Are there the most efficient ways to stop erosion of soils using the help of biotechnology-based tools?
• What can biotechnology do to assist in increasing the levels of vitamin content in GM food items?
• Enhancing the distribution of pesticides by using biotechnology
• Comparing the biofortification of folate in various types of corpses
• Examine the photovoltaic-based generation of ocean-based crop
• What is the best way to use nanotechnology will improve the efficiency of the agriculture sector?
• Analyzing the mechanisms that govern resistance to water stresses in models of plants
• Production and testing of human immune boosters within the test organisms
• Comparing genomic analysis to the usefulness of tools intended for bioinformatics
• The Arabinogalactan protein sequence and its value in the field of computational methods
• Analyzing and interpreting gut microbiota from model organisms
• Different methods of purification of proteins A comparative analysis
• The diagnosis of microbes and their function in micro-arrays of oligonucleotide oligonu
• The use of diverse techniques within the biomedical research field that includes micro-arrays technology
• The use of microbial community to produce the greenhouse effect
• Evaluation of the computational properties of various proteins that are derived from the marine microbiota
• E.coli gene mapping through the help of different tools for microbial research
• Intensifying the strains of Cyanobacterium the aid of gene sequencing
• Assessment and description by computation of crystallized proteins that are found in the natural world.
• MTERF protein and the use of it to end the process of transcription that occurs in mitochondrial DNA inside algae
• Reverse column chromatography in phase and its use in the separation of proteins
• The study of the various proteins that are found within Mycobacterium leprae.
• A review of the methods that are ideal to ensure the success of cloning RNA
• Examine the most common mistakes of biotechnology in conserving the ecology and natural environment.
• Is there a method to ensure that the medicinal plants are free of insects? Discuss
• What are the dangers caused by pest resistant animals on birds and human beings?
• What are the many areas of biotechnology that remain unexplored in terms research?
• What's the future of biotechnology in the medical field?
• Recombinant DNA technology to develop of new medical treatments
• What is the reason for the type of bacteria that is used to make vaccines with the aid of biotechnology?
• How can biotechnology aid in the development of new medicines that are resistant to the mutations of viruses and bacteria?
• Is there a long-term treatment for cancer that is available in the near term? Biotechnology could play an essential role in this?
• What is the reason it is so important that students remember the DNA codes in biotechnology?
• How can we create hybrid seeds with assistance of biotechnology?
• How can one create resistant plants to pests and what are the benefits of these seeds in final yields in agriculture?
• Examine bio-magnification and its effects on the ecology
• What are the causes to the reasons ecologists do not approve the use of pest-resistant seed, even though they are in application in agriculture?
• How has biotechnology influenced the lives of farmers in developing countries?
• Biotechnology can be used to boost the yield of plant species?
• Examine the role played by biotechnology to increase the production of the seasonal crops
• Are there any adverse side effects associated with pharmaceutical drugs when they are manufactured with biotechnological techniques? Let the issue with real-world examples

We attempted to cover the essential topics needed for research work. Other topics are available that could be picked based on our interests, the facilities available and resources available for the research, as well as resources and time limits.

We have reached the end of this list. We feel it was beneficial in satisfying the selection criteria. Furthermore, the inclusion of biotechnology-related assignment themes was done in such a manner that they may help us with the requirements of assignment writing kinds and forms. The themes listed above can meet our demands for topic selection linked to aid with case studies and essay assistance, research paper writing help , or thesis writing help .

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Top 50 Emerging Research Topics in Biotechnology

Trending Research Topics in Biotechnology

Biotechnology is a dynamic field that continuously shapes our world, enabling innovation, breakthroughs, and solutions to various challenges. As we move into the future, numerous emerging research areas promise to revolutionize healthcare, agriculture, environmental sustainability, and more. The top 50 emerging research topics in biotechnology are presented in this article.

1. Gene Editing and Genomic Engineering

a. CRISPR and Gene Editing

Precision Medicine : Developing targeted therapies for various diseases using CRISPR/Cas9 and other gene-editing tools.

Ethical Implications : Exploring and addressing ethical concerns surrounding CRISPR use in human embryos and germline editing.

Agricultural Advancements : Enhancing crop resistance and nutritional content through gene editing of improved farm outcomes.

Gene Drive Technology : Investigating the potential of gene drive technology to control vector-borne diseases like malaria and dengue fever.

Regulatory Frameworks : Establishing global regulations for responsible gene editing applications in different fields.

b. Synthetic Biology

Bioengineering Microbes : Creating engineered microorganisms for sustainable production of fuels, pharmaceuticals, and materials.

Designer Organisms : Designing novel organisms with specific functionalities for environmental remediation or industrial processes.

Cell-Free Systems : Developing cell-free systems for various applications, including drug production and biosensors.

Biosecurity Measures : Addressing concerns regarding the potential misuse of synthetic biology for bioterrorism.

Standardization and Automation : Standardizing synthetic biology methodologies and automating processes to streamline production.

2. Personalized Medicine and Pharmacogenomics

a. Precision Medicine

Individualized Treatment : Tailoring medical treatment based on a person’s genetic makeup and environmental factors.

Cancer Therapy : Advancing targeted cancer therapies based on the genetic profile of tumors and patients.

Data Analytics : Implementing big data and AI for comprehensive analysis of genomic and clinical data to improve treatment outcomes.

Clinical Implementation : Integrating genetic testing into routine clinical practice for personalized healthcare.

Public Health and Policy : Addressing the challenges of integrating personalized medicine into public health policies and practices.

b. Pharmacogenomics

Drug Development : Optimizing drug development based on individual genetic variations to improve efficacy and reduce side effects.

Adverse Drug Reactions : Understanding genetic predispositions to adverse drug reactions and minimizing risks.

Dosing Optimization : Tailoring drug dosage based on an individual’s genetic profile for better treatment outcomes.

Economic Implications : Assessing the economic impact of pharmacogenomics on healthcare systems.

Education and Training : Educating healthcare professionals on integrating pharmacogenomic data into clinical practice.

3. Nanobiotechnology and Nanomedicine

a. Nanoparticles in Medicine

Drug Delivery Systems : Developing targeted drug delivery systems using nanoparticles for enhanced efficacy and reduced side effects.

Theranostics : Integrating diagnostics and therapeutics through nanomaterials for personalized medicine.

Imaging Techniques : Advancing imaging technologies using nanoparticles for better resolution and early disease detection.

Biocompatibility and Safety : Ensuring the safety and biocompatibility of nanoparticles used in medicine.

Regulatory Frameworks : Establishing regulations for the use of nanomaterials in medical applications.

b. Nanosensors and Diagnostics

Point-of-Care Diagnostics : Developing portable and rapid diagnostic tools for various diseases using nanotechnology.

Biosensors : Creating highly sensitive biosensors for detecting biomarkers and pathogens in healthcare and environmental monitoring.

Wearable Health Monitors : Integrating nanosensors into wearable devices for continuous health monitoring.

Challenges and Limitations : Addressing challenges in scalability, reproducibility, and cost-effectiveness of nanosensor technologies.

Future Applications : Exploring potential applications of nanosensors beyond healthcare, such as environmental monitoring and food safety.

4. Immunotherapy and Vaccine Development

a. Cancer Immunotherapy

Immune Checkpoint Inhibitors : Enhancing the efficacy of immune checkpoint inhibitors and understanding resistance mechanisms.

CAR-T Cell Therapy : Improving CAR-T cell therapy for a wider range of cancers and reducing associated side effects.

Combination Therapies : Investigating combination therapies for better outcomes in cancer treatment.

Biomarkers and Predictive Models : Identifying predictive biomarkers for immunotherapy response.

Long-Term Effects : Studying the long-term effects and immune-related adverse events of immunotherapies.

b. Vaccine Technology

mRNA Vaccines : Advancing mRNA vaccine technology for various infectious diseases and cancers.

Universal Vaccines : Developing universal vaccines targeting multiple strains of viruses and bacteria.

Vaccine Delivery Systems : Innovating vaccine delivery methods for improved stability and efficacy.

Vaccine Hesitancy : Addressing vaccine hesitancy through education, communication, and community engagement.

Pandemic Preparedness : Developing strategies for rapid vaccine development and deployment during global health crises.

5. Environmental Biotechnology and Sustainability

a. Bioremediation and Bioenergy

Biodegradation Techniques : Using biotechnology to enhance the degradation of pollutants and contaminants in the environment.

Biofuels : Developing sustainable biofuel production methods from renewable resources.

Microbial Fuel Cells : Harnessing microbial fuel cells for energy generation from organic waste.

Circular Economy : Integrating biotechnological solutions for a circular economy and waste management.

Ecosystem Restoration : Using biotechnology for the restoration of ecosystems affected by pollution and climate change.

b. Agricultural Biotechnology

Genetically Modified Crops : Advancing genetically modified crops for improved yields, pest resistance, and nutritional content.

Precision Agriculture : Implementing biotechnological tools for precise and sustainable farming practices.

Climate-Resilient Crops : Developing crops resilient to climate change-induced stresses.

Micro-biome Applications : Leveraging the plant micro-biome for enhanced crop health and productivity.

Consumer Acceptance and Regulation : Addressing consumer concerns and regulatory challenges related to genetically modified crops.

The field of biotechnology is a beacon of hope for addressing the challenges of our time, offering promising solutions for healthcare, sustainability, and more. As researchers explore these emerging topics, the potential for ground-breaking discoveries and transformative applications is immense.

I hope this article will help you to find the top research topics in biotechnology that promise to revolutionize healthcare, agriculture, environmental sustainability, and more.

• Drug delivery
• Environmental Engineering
• Gene editing
• Genomic Engineering
• Molecular Biology
• Nanoparticles
• Pharmacogenomics
• Research Ideas
• Synthetic biology

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What is Biotechnology?

What first pops up in your mind when you hear the term Biotechnology? Maybe you started thinking of GMOs ( Genetically Modified Organisms ), transgenic cloning, and other gene therapies. Of course, you got it right, but the horizon of biotechnology is not so tiny. It has a wide range of applications in the industry that can improve our living standards. Let us first understand the term Biotechnology. In simple words, it is the utilization of living organisms or their components in the industrial sector to generate various products that are beneficial for the human race. We have been utilizing microorganisms for more than thousands of years to develop useful commodities such as cheese, bread, and various other dairy-related products. Even its implementation in the medical sector has led to the manufacturing of different vaccines, biofuel, chitosan-coated dressing for wounds, brewing, and even age-defying products. As the biotechnology scope is expanding day by day, researchers felt an urge to classify main areas and types of biotechnology depending on some commonalities and their ultimate objectives:

Red Biotechnology- involves the utilization of organisms for upgrading the quality of health care departments and aiding the body’s immune system to fight against various diseases. Examples include; the development of different vaccines, antibiotics, medicinal drugs, and various molecular techniques.

White Biotechnology- mainly comprises industrial biotechnology and involves the utilization of microorganisms and their by-products for manufacturing more eco-friendly and energy-efficient products. White biotechnology examples include the production of biofuel, Lactic acid, and 3- hydroxy propionic acid.

Yellow Biotechnology- it is related to the use of Biotech in the food production area, i.e., making bread, cheese, beer, and wine by the fermentation process.

Grey Biotechnology – mainly deals with the removal of pollutants from the environment by using various microorganisms and plants. For example., different strains of bacteria can be used for the degradation of kitchen waste into compost.

  Green Biotechnology- concentrates on the agriculture sector and focuses on generating new varieties of plants and producing good quality bio-pesticides & bio-fertilizers.

  Blue Biotechnology – it mainly refers to the utilization of aquatic or marine organisms to create goods that can aid various industrial processes, such as using Chitosan (sugar derived from the shells of crabs and shrimps) for the dressing of wounds.

Biotechnology Topics for Research Paper

In the modern world, students are apprehending the benefits of Biotech and want to study it with more enthusiasm and interest. They are actively opting for this subject and compiling their research work to contribute their efforts in the field of Biotechnology. They are indulged in exhaustive research to find the best topic for the research purpose. So, here are a few potential research topics in the domain of Biotechnology:

Red Biotechnology Research Topics:

• Studying the relationship between the intake of iron-folic acid during pregnancy and its impact on the overall health of the fetus.
• Pharmacogenomics of antimicrobial drugs.
• Identifying the biomarkers linked with breast cancer.
• Study the medicinal value of natural antioxidants.
• Study the structure of coronavirus spike proteins.
• Studying the immune response of stem cell therapy.
• Utilization of CRISPR-Cas9 technology for genome editing.
• Application of Chitosan in tissue engineering and drug delivery.
• Study the therapeutic effects of cancer vaccines.
• Utilizing PacBio sequencing for the genome assembly of model organisms.
• Study the relationship between the suppression of mRNA and its effect on stem cell expansion.
• Study the application of nanoprobes in molecular imaging.
• Incorporating biomimicry for the detection of tumor cells.
• Study of immune-based therapies in treating COVID-19.
• Regulation of immune response using the cellular and molecular mechanism
• Microchip implantation – a vaccine for coronavirus.
• The Use of CRISPR for Human Genome Editing

Yellow Biotechnology Research Topics:

• Production of hypoallergenic milk.
• Production of hypoallergenic fermented foods.
• Yellow enzymes subclassification and their characterization.

White Biotechnology Research Topics:

• Bioconversion of cellulose to yield industrially important products.
• Studying the inhibitors of endocellulase and exocellulase.
• Fungal enzymes used in the production of chemical glue.
• Mechanism of fungal enzymes in the biodegradation of lignin.
• Studying gut microbiota in model organisms.
• Study the lactic acid bacteria for probiotic potential.
• Purification of thermostable phytase.
• Mesophilic and Thermophilic aerobic and anaerobic bacteria from compost.
• Study the dietary strategies for the prophylaxis of Alzheimer’s and dementia.
• Examine the positive effects of probiotics and prebiotics on the nervous system.

Examples of Grey Biotechnology Research Topics:

• Production of sustainable, low-cost, and environmentally friendly microbial biocement and biogrouts.
• Use of microorganisms for the recovery of shale gas.
• Studying the procedure of natural decomposition.
• Treatment of grey water in a multilayer reactor with passive aeration.
• Excavation of various anaerobic microbes using grey biotechnology.
• Improving the biodegradation of micro-plastics using GMOs.
• Removal of pollutants from the land.
• Use of microbes to excavate the hidden metals from earth.
• Managing the processes of environmental biotechnology using microbial ecology.
• In situ product removal techniques using the process of biocatalysis.
• Production of biodegradable, disposable plastic for the storage of food.
• Plastic waste decomposition management.  
• Maintaining a healthy equilibrium between biotic and abiotic factors using biotechnological tools.
• Recycling of biowastes.
• Restoration of biodiversity using tools.
• Improved Recombinant DNA technology for bioremediation.
• Gold biosorption using cyanobacterium.
• Improved bioremediation of oil spills.
• Biodegradation of oil and natural gas.

Blue Biotechnology Research Ideas:

• Various bioactive compounds derived from marine sponges.
• Controlling the emerged biological contaminant using the sustainable future.
• Protecting the environment using grey, blue, and green biotechnology.  
• Exploring marine biota which survives the extreme conditions.
• Studying the patterns of Arctic and Antarctic microbiota for the benefits of humans.
• Excavation of bioactive molecules from extreme environmental conditions.
• Studying the potential of sponge-associated microbes.
• Mercury labeling in the fish using markers.
• Sea urchin repelling ocean macroalgal afforestation.
• Microbial detection techniques to find sea animals.
• Studying the mechanisms in deep-sea hydrothermal vent bacteria.
• Production of antibiotics using marine fungi.
• Exploring the biotechnological potential of Jellyfish associated microbiome.  
• Exploring the potential of marine fungi in degrading plastics and polymers.
• Expl oring the biotechnological potential of dinoflagellates.

Green Biotechnology Research Paper Topics:

• Detection of endosulfan residues using biotechnology in agricultural products.
• Development of ELISA technique for the detection of crops’ viruses.
• Use of Green Fluorescent Protein (GFP) as a cytoplasmic folding reporter.
• E.coli as an all-rounder in biotechnological studies.
• Improving the water quality for drinking using E.coli consortium.
• E.coli characterization isolated from the zoo animals’ feces.  
• Biocatalysis and agricultural biotechnology in situ studies.
• Improving the insect resistance of the crops.
• Improving the nutritional value and longer shelf life of GM crops.
• Improving the qualities of hydroponic GM plants.
• Reducing the cost of agriculture using bio-tools.
• Production of heavy cotton balls in agricultural biotechnology using in situ technique.
• Steps to minimize soil erosion using the tools of biotechnology.
• Enhancement of vitamin levels in GM Foods .
• Improving pesticide delivery using biotechnology.
• Comparison of folate biofortification of different crops.
• Photovoltaic-based production of crops in the ocean.
• Application of nanotechnology in the agricultural sector.
• Study the water stress tolerance mechanisms in model plants.

Combination and Analytical Topics:

• Sequencing of infectious microbes using molecular probes.
• Production and testing of human immune boosters in experimental organisms.
• Comparative genomic analysis using the tools of bioinformatics.
• Arabinogalactan protein sequencing using computational methods.
• Comparative analysis of different protein purification techniques.
• Oligonucleotide microarrays used in the diagnosis of the microbes.
• Uses of different techniques in biomedical research including microarray technology.
• Microbial consortium used to produce the greenhouse effect.
• Computational analysis of different proteins obtained from marine microbiota.
• Gene mapping of E.coli using different microbial tools.
• Computational analysis and characterization of the crystallized proteins in nature.
• Improving the strains of cyanobacterium using gene sequencing.
• mTERF protein used to terminate the mitochondrial DNA transcription in algae.  
• Reverse phase column chromatography used to separate proteins.
• Study of different proteins present in Mycobacterium leprae.
• Study the strategies best suitable for cloning RNA
• Study the application of nanocarriers for the gene expression in model plants.
• Exploring thermotolerant microorganisms for their biotechnological potential.

Biotechnology is full of research prospects. Various research and development companies are working day and night to achieve the required outcomes for different branches of biotechnology. If you find these list of Biotechnology research topics helpful, you may visit our blog for further assistance.

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• v.12(11); 2022 Nov

Emerging biotechnology applications in natural product and synthetic pharmaceutical analyses

Shilin chen.

a Institute of Herbgenomics, Chengdu University of Traditional Chinese Medicine, Chengdu 611137, China

b Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China

c State Key Laboratory of Component Traditional Chinese Medicine, College of Pharmaceutical Engineering of Traditional Chinese Medicine, Haihe Laboratory of Modern Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China

Sanyin Zhang

d Innovative Institute of Chinese Medicine and Pharmacy, Chengdu University of Traditional Chinese Medicine, Chengdu 611137, China

Xiaohe Xiao

e China Military Institute of Chinese Medicine, Fifth Medical Center of Chinese PLA General Hospital, Beijing 100039, China

Qinghe Zhao

Shasha kong.

Pharmaceutical analysis is a discipline based on chemical, physical, biological, and information technologies. At present, biotechnological analysis is a short branch in pharmaceutical analysis; however, bioanalysis is the basis and an important part of medicine. Biotechnological approaches can provide information on biological activity and even clinical efficacy and safety, which are important characteristics of drug quality. Because of their advantages in reflecting the overall biological effects or functions of drugs and providing visual and intuitive results, some biotechnological analysis methods have been gradually applied to pharmaceutical analysis from raw material to manufacturing and final product analysis, including DNA super-barcoding, DNA-based rapid detection, multiplex ligation-dependent probe amplification, hyperspectral imaging combined with artificial intelligence, 3D biologically printed organoids, omics-based artificial intelligence, microfluidic chips, organ-on-a-chip, signal transduction pathway-related reporter gene assays, and the zebrafish thrombosis model. The applications of these emerging biotechniques in pharmaceutical analysis have been discussed in this review.

Graphical abstract

Pharmaceutical analysis (PA) is a discipline dominant by chemical and physical technologies, with week role of biological and information technologies. Here, the applications of emerging biotechnologies in PA are reviewed.

1. Introduction

Pharmaceutical analysis is a discipline based on chemical, physical, biological, and information technologies. Chemical substances are the basis for drugs to exert their therapeutic effects, and chemical-based analytical methods were the first to receive attention. The physical properties of a drug ( e.g. , uniformity and crystal form) can also affect its quality and have thus received attention. Nevertheless, biotechnology and latest information technology have not received enough attention from pharmacists.

The role of biotechnology in pharmaceutical analysis is weak ( Fig. 1 A). The number of papers published in the last 15 years (2007–2022) included in the Web of Science was searched with the keywords “pharmaceutical analysis” combined with “chemical analysis” or “biological analysis”. The number of papers published every five years are shown in Fig. 1 B, indicating that chemical analysis still plays a dominant role in pharmaceutical analysis, whereas the role of biological analysis is limited. Although chemical and physical methods show high accuracy, sensitivity, throughput, and robustness, some of the detected index components do not represent the efficacy or effectiveness of natural products, which is related to the complex action mechanism of natural products with complex composition.

Overview of current pharmaceutical analysis methods.

Biological analysis is the basis and an important part of life science, particularly medicine, and the development of biotechnology has advanced the field of medicine 1 . Because of their advantages in reflecting the overall biological effects, function, or action mechanism of drugs and providing visual and intuitive results, some biotechnologies have been gradually applied to pharmaceutical analysis ( Fig. 2 ) from raw material to manufacturing and final products. Biological detection methods are the core evaluation techniques used to study the effectiveness, safety, and quality of drugs 2 . In this review, the applications of these emerging biotechnologies in pharmaceutical analysis are summarized and discussed.

Emerging biotechnologies and bioinformatics for pharmaceutical analysis.

2. Application of biotechnology for raw material analysis

The current biotechnologies for the raw material analysis of animal and herbal medicine in the Chinese Pharmacopoeia (2020) are polymerase chain reaction (PCR) and polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP). Other novel and convenient biotechnological technologies 3 are being adopted in actual application and are discussed in Table 1 and Fig. 3 .

Application of detection methods based on biotechnology in raw materials.

Biotechnological methods to detect raw materials.

2.1. Molecular technologies for identifying the authenticity of raw materials

With the continuous upgradation of sequencing technology and the continuous decline in sequencing cost, the genetic information of many species has been obtained, and different databases have been established 24 , 25 , which lays the foundation for the development of molecular identification technology and the breeding of new varieties 26 . Barcoding, molecular markers, and rapid detection are technologies based on DNA and can accurately identify raw materials.

2.1.1. Barcoding

Barcoding is widely used to identify plant and animal materials. It uses a standard and relatively short sequence for species identification and is not affected by ontological development stages. Single barcodes, such as internal transcribed spacer ( ITS )/ ITS2 , trnH-psbA , MatK , RbcL , and COI , were first used to identify the authenticity of raw materials. ITS/ITS2 was used to distinguish different species of Euphorbiaceae 27 and Apocynaceae 28 and identify cultivated varieties of Paeonia lactiflora 4 . COI can accurately identify snake medicine 29 . ITS2 has high identification ability for ultrafine powder or cell wall-broken powder 30 . Two- and three-loci combinations were also used to identify the authenticity of raw materials. matK and rbcL were used to identify Arisaematis Rhizoma, Pinelliae Tuber, and common adulterants 31 . matK and rbcL combined with trnH-psbA are the ideal barcodes to discriminate Kaempferia and their adulterants 32 . However, these barcodes have limited mutation sites and low identification ability for related species. As a super-barcode with sufficient genetic variation, the chloroplast genome has been used to identify Crataegus and its related species 5 . In addition, the large single-copy region of chloroplast genome is used to identify Dendrobium species 33 .

2.1.2. Molecular markers

Molecular markers reveal the arrangement rules of genes and the expression rules of phenotypic traits by analyzing DNA fragments with genetic information differences among organisms. They are not affected by the external environment, developmental stages, and differences among tissues and organs, and can detect various organs, tissues, and even cells of organisms in different developmental stages. These markers have the advantages of wide distribution, abundance, stable traits, convenient selection, simple operation, and rapid detection and have been widely used in the analysis and identification of herbal medicines. For example, insertion/deletion (InDel) markers distinguish different species by analyzing differences in gene insertion or deletion nucleotide fragments in the same position between related species or different individuals of the same species. Kim et al. 6 accurately distinguished Zanthoxylum schinifolium and Zanthoxylum piperitum by the InDel analysis of psbZ-trnG . Simple sequence repeat (SSR) can be used to mark 2–6 bases of tandem repeats in genetic information, and this method could accurately distinguish multiple cultivars of plum varieties 34 . Inter-simple sequence repeat (ISSR) markers developed based on SSR can anchor 2–4 random bases at the 5′ or 3′ end of SSR as primers and anneal at a specific site. This method was used for the systematic classification and identification of Hedyotis diffusa 35 . Expressed sequence tags are molecular markers developed on expressed sequences and cDNA and can be used to distinguish species populations such as Ligusticum chuanxiong 36 . Single nucleotide polymorphism (SNP) is the DNA sequence polymorphism caused by single nucleotide variation and can be used to screen excellent varieties and identify species such as Panax ginseng 37 . In addition, many molecular markers are combined with PCR for species identification, such as sequence-related amplified polymorphism for identifying wild resources and cultivated varieties of Platycodon grandiflorus 38 , sequence-characterized amplified regions for distinguishing Angelica dahurica 7 and mistletoe species 39 from their related varieties, PCR-RFLP for identifying Ophiocordyceps sinensis and its powder samples, and random amplified polymorphic DNA for distinguishing Viscum coloratum 40 .

2.1.3. Rapid detection based on biotechnology

Most biological rapid detection techniques were developed from PCR amplification. High-resolution melting (HRM), multiplex PCR, and real-time PCR are commonly used to identify raw materials. HRM is a genotyping technique based on the formation of different morphological dissolution curves of double-stranded DNA at different dissolution temperatures. As a tool for species identification, HRM was used for plant origin identification 41 . HRM was also combined with DNA barcoding and SSR to distinguish Akebia quinata , Artemisia , and Glycyrrhiza uralensis 42 , 43 . Multiplex PCR with two or more pairs of primers in the same reaction system can amplify different templates and obtain different target fragments. It was used to detect Longan Arillus, Litchi Semen, and Nephelium lappaceum 44 . Fluorescent groups or probes were added to the real-time quantitative PCR system for real-time monitoring of the whole PCR process by the accumulation of fluorescent signals. Zhang 45 identified donkey, horse, pig, and cattle and their hide gelatin by selecting the COI gene using TaqMan RT-PCR. Meanwhile, the dye quantitative RT-PCR method can be used to identify P. ginseng and Fritillaria cirrhosa .

Isothermal amplification can identify raw materials, does not depend on the PCR instrument, and can be used on site. In helicase-dependent amplification, the target fragment is melted to form a single chain under the action of a helicase. The single-chain binding protein is combined with DNA single chain, the target fragment is kept in a single-chain state, a primer is combined with the single-chain DNA to amplify the target fragment, and the amplified double-chain DNA is used as a substrate for the next amplification cycle. This method has been used for identifying the authenticity of P. ginseng and its preparations 46 . Loop-mediated isothermal amplification (LAMP) hybridizes six to eight fragments of the target sequence with BstDNA polymerase and four to six pairs of specific primers under constant temperature. LAMP experimental results were judged by eye by changing the color of the experimental solution or using a turbidimeter. This method has been used for the authenticity identification of Pheretima aspergillum and Cordyceps sinensis 8 . Recombinase polymerase amplification (RPA) features recombinant protease and forward and reverse primers that form a complex under the action of auxiliary factors. The complex searches for and binds to a target site on a target sequence. Under the action of recombinase, primer, and single-chain binding protein, the target fragment is kept in a single-chain state. The amplification of the target sequence is then promoted by DNA polymerase. Finally, the experimental results were observed by real-time monitoring or electrophoresis with fluorescent probes. This method has been used to identify Gelsemium elegans 47 and is often combined with lateral flow test paper to quickly identify raw materials.

Molecular technology has been used for rapid and accurate identification of medicinal materials due to its rapid, trace, and strong specificity. However, these methods cannot identify the adulteration of non-pharmaceutical parts of medicinal materials and classify their quality grade.

2.2. Chips and probes to identify and detect raw materials

2.2.1. chips.

Chip technology has been used to detect the authenticity of raw materials, heavy metals, and pesticide residues. Gene chips integrate oligonucleotide or cDNA in high density according to the preset nucleic acid molecule hybridization derivative array and then fix it on the surface of the support carrier. After the carrier surface hybridizes with the probe, the biological signal is captured by a special device comprising semiconductor sensors, and the content is recorded synchronously and sent back to the computer for analysis. Finally, the gene function and gene phenotype characteristics of the carrier sample can be obtained. Gene chips can distinguish Bupleurum chinense from different sources to ensure its authenticity 48 . Diversity arrays technology was used to distinguish Eucalyptus grandis from related species. The protein chip sequentially immobilizes some known proteins on a carrier, specifically interacts with known molecules according to their molecular characteristics, and performs purification and subsequent processing to quickly and accurately screen the protein component. This method can be used for identifying Chinemys reevesii and Pheretima aspergillum 9 . Microfluidic chips can manipulate fluids in micro- and nanoscale spaces and miniaturize the basic functions of sample preparation, reaction, separation, and detection onto a portable microchip for the flexible combination and scale integration of multiple cell technologies on a controllable microplatform. Detection techniques using this tool, such as electrochemical microfluidics 49 , can detect heavy metals and pesticides to control the safety of raw materials 10 . Chip technology has the advantages of short detection cycle and high efficiency. However, chip technology still has shortcomings such as high false positives, requiring simplified preparation, labeling of test samples, and high cost of gene chip application.

2.2.2. Probes

Multiplex ligation-dependent probe amplification (MLPA) detects differences in gene copy number in DNA methylation, and single base variation by four steps: target DNA denaturation, probe hybridization, ligase linking of left and right probes, and PCR amplification. MLPA designed for ITS1 could realize the identification and quantitative analysis of Fritillariae cirrhosae and its common counterfeits 11 . The fluorescent probe is connected to the recognition group to form small molecules, which can stably emit fluorescence after being electrified. In addition, the fluorescent probe can be observed and quantified by a fluorescence index meter. The method can be used for sensitively detecting Hg 2+ in samples 12 . The probe technology has the characteristics of high sensitivity and strong specificity. However, the difficulty in probe design and the high cost of labeling have become limiting factors in their application. Therefore, developing a simple and convenient probe detection method is necessary.

2.3. Biosensors for raw material detection

Biosensors use active substances, such as enzymes and microorganisms, as sensitive materials for recognition and convert biological information to electrical signals with high sensitivity, accuracy, and stability in real time. This technology has been used to detect the authenticity of raw materials, heavy metals, and pesticide residues. Shi designed a sequencing-free electrochemical herb sensor based on the ITS2 of Crocus sativus to identify the plant and its counterfeits 13 . Lei explored an efficient and simple electrochemical sensor to prepare carbon-supported X-manganate for the detection of Pb 2+ and Hg 2+14 . Enzyme biosensors can calculate the pesticide residue level in a sample by measuring the degree to which the enzyme activity (fixed on the electrode surface) is inhibited by pesticides. Hana Fourou fixed β -galactosidase from Aspergillus oryzae on the electrochemical sensor to detect Cr 4+ and Cd 2+ , 50 . Enzyme biosensors based on cholinesterase enzymes, organophosphorus hydrolase, and organophosphorus acid anhydrolase were used to detect organophosphorus pesticides 15 . Whole-cell biosensors are based on microorganisms. Kim modified Escherichia coli strains to contain copA , zntA , and mer promoters and inserted the luciferase ( lux ) gene as the reporter gene into the plasmid to respond to the induction of copper, cadmium, and mercury, respectively, to detect heavy metals 51 . Tu designed a nanochannel sensor made of Pb 2+ -specific peptide modified porous anodized aluminum membrane to detect lead ions in complex traditional Chinese medicine (TCM) samples 52 . Pesticide residues of imidacloprid 16 and thiamethoxam 17 are often detected by molecularly imprinted sensors. Immunosensors are a biological sensing device based on affinity that combine immunochemical reactions with an appropriate sensor. Glyphosate, atrazine, and parathion can be detected by immunosensors 18 . The electronic nose can analyze trace odor substances, compare odor similarities in samples, and establish a corresponding database by pre-collecting standard samples for the prediction and evaluation of unknown samples. It is used for the identification of volatile constituents and pesticide residues 53 .

2.4. Immunoassay to detect harmful substances in raw materials

Immunoassay is based on specific antigen–antibody reaction and uses a detection method for antigen and labeled antigen competitive binding antibody. Immunoassay techniques used to detect harmful substances include enzyme-linked immunosorbent assay (ELISA), fluorescent immunoassay (FIA), chemiluminescent immunoassay (CLIA), and gold immunochromatographic assay (GICA). ELISA uses enzymes as tracers to mark antigens or antibodies, and the enzyme catalyzes the substrate to develop color or emit light to establish the relationship between the developed color degree of the system and the content of the substance to be tested. Ethylene thiourea 54 , neonicotinoid 55 , and imidacloprid 19 were tested using ELISA. FIA uses fluorescein as a tracer to label antibodies or antigens and combines the specificity of immunological reactions with the sensitivity of fluorescence techniques. Acetochlor, metolachlor, and propisochlor were detected using this technology 20 . CLIA directly labels a luminescent substance of an excited state intermediate generated under excitation of a reactant on an antigen or an antibody and combines high-sensitivity chemiluminescence determination with high-specificity immune reaction. Parathion, methyl parathion, fenitrothion 21 , and Cu 2+ 22 were detected by this method. GICA uses colloidal gold as the tracer marker. Gold particles have high electron density, and black-brown particles at the binding site of gold-labeled protein can be observed under the microscope. When these markers accumulate in large amounts at the corresponding ligands, red or pink spots can be visualized with the naked eye. This technology is often used in combination with lateral flow strips (LFS) to detect pesticide residues such as carbendazim 23 . In addition, colloidal silver-based lateral flow immunoassay is used to detect profenofos 56 .

Immunoassay is the most widely used method to detect pesticide residues. However, preparing pesticide antibodies is difficult and the development cost is high. It is only suitable to detect pesticide residues in a single product and not for multi-residue analysis. Therefore, establishing a high-throughput immunoassay technique is particularly important.

3. Application of biotechnology in pharmaceutical manufacturing control

Conventional pharmaceutical manufacturing is usually accomplished using batch processing with laboratory testing conducted on collected samples to evaluate quality. This conventional approach has been successful in providing quality medicine to some extent. Although the quality of newly introduced products has increased, concerns over pharmaceutical product quality persist due to unacceptably high product recalls. Natural products are well-known for their complex multi-compound, multi-ingredient formulation and preparations 57 , and large variation in the quality of products from different manufacturers or different batches by the same manufacturer. Thus, process monitoring in natural product manufacturing has been a challenging topic.

Process analysis technology (PAT) was proposed as a system for designing, analyzing, and controlling manufacturing by timely measurement ( i.e. , during processing) of critical quality and performance attributes of raw and in-process materials and processes to ensure the final product quality. The term “analysis” in PAT is broadly viewed to include chemical, physical, and biopharmaceutical characteristics in an integrated manner. However, most quality control techniques in pharmaceutical production focus on the analysis of physicochemical properties. Given that natural products are complex mixtures, this chemical complexity brings great difficulty for current chromatographic and spectroscopic techniques based on the chemical approach to detect all their components 58 . In addition, chemical information lacks enough evidence to ensure the clinical safety and efficacy of drugs because the correlation between chemical information provided by the chemical approach and overall in vivo activity has not been justified 59 . Many substances, particularly certain biological active ingredients and bio-pollutants, cannot be detected by chromatographic methods because of the lack of absorption in spectra. Biotechnology has been used to control the quality of natural products and synthetic pharmaceuticals. Although biotechnological approaches cannot provide chemical information (chemical components), they have the advantage of offering information on the direct bioactivity and even clinical safety and efficacy of biological products 60 . The application of biotechnology in pharmaceutical manufacturing control is shown in Fig. 4 and Table 2 .

Biotechnologies in pharmaceutical manufacturing process control and intermediate analysis.

Application of biotechnology in pharmaceutical manufacturing control.

3.1. Process monitoring

3.1.1. biological and chemical coupling for pharmaceutical processes.

Currently, only a few bioassays have met the assay requirements of multiplexing, sensitivity, and speed. Detection approaches with multiplexing capabilities are highly valued for natural products because of their multi-component and multi-target characteristics. Thus, biological assays that can be integrated with chemical analyses are being explored. Such integration capability can enable parallel chemical and biological analyses on the same analytical platform, thereby reducing instrument cost and variations between instruments.

Recent advances in ambient ionization technology have opened up the opportunity of using mass spectrometry (MS) to be an innovative PAT tool in natural product manufacturing 75 . Li et al. 61 proposed an on-demand strategy based on direct analysis in real time-mass spectrometry (DARTMS), which uses an MS probe as the substrate of the enzyme to determine the biological activity of selected thrombin and angiotensin-converting enzyme (ACE). Each probe consists of a specific peptide sequence and 1-(2-pyrimidyl) piperazine as a label with high ionization efficiency. The strategy achieved the simultaneous determination of the chemical components and biological activities of Danshen ( Salvia miltiorrhiza ) injection. The detection results showed that the platform can achieve multi-dimensional drug quality evaluation under real-time monitoring.

3.1.2. Biological soft sensing for quality control in pharmaceutical processes

The heterogeneous nature of natural products causes variability in raw materials and drug products, leading to uncertainty in their therapeutic consistency. Therefore, multi-dimensional quality control is essential to ensure the safety and efficacy of these drug products. Using different tools for the quality analysis of different dimensions results not only in high costs but also in variations between instruments. Soft sensing is a new and popular method in the field of monitoring 76 . This technology realizes the real-time estimation of the quality or activity that is difficult to directly measure by easily detectable indicators and the corresponding mathematical model. Therefore, soft sensing shows good performance on detecting difficult-to-measure quality indicators in pharmaceutical and other industrial processes.

Taking Shuxuening injection as an example, Zhong et al. 73 used hyperspectral imaging (HSI) combined with artificial intelligence (AI) as a biological soft sensing technology to simultaneously monitor physical properties, chemical components, and biological activities of the injection in a non-destructive manner. The detection of chemical components in drugs often requires analytical equipment such as high-performance liquid chromatography (HPLC). Antioxidant and anticoagulant activities require the use of DPPH-free radical scavenging assay and Z-Gly-Gly-Arg-AMC acetate probe substrate. The chromaticity and visible particles of the injection are detected using image recognition algorithms. The HSI-AI method predicted the five quality indicators of total flavonol, total ginkgolides, antioxidant activity, anticoagulant activity, and visible particles. Thus, the platform can be used for the process monitoring of multiple quality characteristics in pharmaceutical production.

Biological soft-sensing techniques combined with HSI can simultaneously acquire multiple quality attributes of a sample under non-destructive conditions. It is worth noting that soft measurement is an indirect measurement technique. Therefore, standard methods must be used to detect the quality indicators of the samples in advance, and then the correlation model between the sample quality and the HSI data must be established. The upper limit of the accuracy of the soft measurement is the measurement accuracy of the standard method.

3.2. Intermediate product analysis

In the pharmaceutical process, differences in natural products and the fluctuation of operating parameters in each process unit may lead to the quality difference in intermediates between batches and affect the quality of the final product. Therefore, the intermediates produced in the process must be subjected to quality control.

3.2.1. Biological and chemical coupling for intermediate product analysis

The diverse sources and production environments of natural products lead to uncertainty about pharmaceutical products. All biological and chemical active ingredients that may affect the quality and effectiveness of medicines are comprehensively and accurately detected.

The main material basis of Shuxuening injection (SI) is its antioxidant effect. Therefore, the qualitative and quantitative analyses of antioxidants in its pharmaceutical process is of importance to ensure its quality. Ma et al. 62 established an ABTS + (2,2-azinobis-(3-ethyl benzothiazoline-6-sulfonic acid))-CE online analytical method for the monitoring of various antioxidants in the preparation of injections. ABTS + was first integrated into the capillary and used for the simultaneous determination and separation of major antioxidants in the injection. The experimental results were verified by SI and showed that the strategy is a simple, reliable, and effective tool for the quantitative evaluation of drugs.

Some markers cannot comprehensively evaluate TCM preparations containing multiple components, thus neglecting the inherent chemical complexity and multiple mechanisms of their pharmacological activity. Wang et al. 63 proposed a strategy for screening Typha orientalis quality using bioactive chemical comprehensive markers based on thrombin and a combination of metabolomics and chemometrics. This research provides ideas for creating methods to simultaneously evaluate the biological and chemical properties of drugs.

3.2.2. Biosensors for intermediate product analysis

Biosensors are small integrated analytical devices consisting of biological components in close contact with physical sensors that convert the biometric process to measurable signals. They provide specific quantitative or semi-quantitative analytical information using biometric elements that convert information from the biological domain into chemical or physical output signals 77 , 78 , 79 .

A study used a label-free biosensor based on surface plasmon resonance (SPR) technology to detect bromocriptine 64 . First, candidate enzymes for the bromocriptine biosensor were screened by protein ligand docking simulation and competitive inhibition experiment to verify the accuracy and reliability of the results. This enzyme SPR method can realize the rapid, real-time, and label-free monitoring of drugs. The results showed that the combination of SPR technology and different enzymes could monitor various drugs. In another study, hollow fiber-based affinity selection was proposed to detect inhibitors from medicinal plant extracts 65 . First, lipase from porcine pancreas was adsorbed onto the surface of polypropylene hollow fibers to form a stable ligand-harvesting matrix. Various factors related to binding capacity, including enzyme concentration, incubation time, and temperature, were then optimized using the known lipase. The proposed method can be used to detect lipase-binding ligands in lotus leaf extracts. As a typical aggregation-induced emission-based fluorophore, tetraphenylethylene (TPE) has a range of applications in biosensors and cell imaging. Wang et al. 66 synthesized TPE-based fluorescent probes by two processes. One is TPE with the carboxylate group synthesized by the McMurray reaction, and the other is TPE-SDKP prepared by standard solid-phase synthesis. This probe can be used to monitor ACE activity and determine the efficiency of ACE inhibitors in extracts.

Aptamers are single-stranded oligonucleotide molecules screened by ligand evolution using an exponential enrichment system with the advantages of good stability, strong specificity, in vitro synthesis, low cost, and easy modification. They serve as an alternative target recognition element for antibodies in biosensors and can overcome the high cost of antibody-based ELISA.

Different aptamer-based sensing platforms have been developed to detect cytotoxins and contaminants in food and pharmaceuticals 80 , 81 , 82 , 83 , 84 , 85 , 86 , 87 , 88 , 89 . Because of their great damage to human health, cytotoxin and other pollutants must be strictly detected in the pharmaceutical process. A recent study used fluorescent acceptors and achieved the simultaneous detection of patulin (PAT) and zearalenone (ZEN) 67 . In this study, the aptamers of PAT and ZEN were labeled with FAM and CY3, respectively, as fluorescent probes. Both aptamers were adsorbed on the surface of graphene oxide (GO) by π–π stacking, resulting in fluorescence resonance energy transfer between the fluorophore and GO. Therefore, this detection platform has good selectivity and reliability in the detection of TCM samples.

The damage caused by pathogenic E. coli to human health has attracted increasing attention 68 . A recent study used an aptamer-based electrochemical biosensor in licorice extracts to rapidly detect pathogenic E. coli 90 . To enhance the interaction between aptamer and E. coli , the sulfuration signal was first captured, followed by biotinylation of E. coli . A portion of the biotinylated aptamer was detached from the capture probe in the presence of E. coli . Residual biotinylated aptamer probes quantitatively bound to streptavidin-alkaline phosphatase. The results showed that the designed biosensor can be used to rapidly detect microbes in TCM and related fields.

Biosensors have the advantages of strong specificity, fast analysis speed, and high accuracy. Biosensors can be integrated with computers to automatically collect and process data, provide more scientific and accurate results, and form an automated detection system. At the same time, chip technology is increasingly combined with sensors to realize the potential of integrated detection systems.

3.2.3. Protein chip for intermediate product analysis

Paper-based microarrays are analytical devices made of paper that have been rapidly developed in recent years 91 , 92 , 93 , 94 . They are low cost, easy to use, and can perform multiple chemical analyses. In addition, these paper devices have a high specific surface area that allows molecules to easily bind and adsorb proteins. Used paper devices can be incinerated to reduce the pollution caused by experimental consumables. The white paper provides an ideal background signal for observing colorimetric reactions.

Paper-based microarrays are an analytical device made of paper and have been developed rapidly in recent years 91 , 92 , 93 , 94 . They are low cost, easy to use, and can perform multiple chemical analyses. In addition, these paper devices have a high specific surface area that allows molecules to easily bind and adsorb proteins. Used paper device can be incinerated to reduce the pollution caused by experimental consumables. The white paper provides an ideal background signal for observing colorimetric reactions. Gong et al. 69 proposed an effective omics technology to prepare paper-based microarrays and used them to detect active components in TCM extracts. Polycaprolactone/chitosan-modified paper was prepared by 3D printing (3DP), and α -glucosidase was immobilized on the modified paper. The strategy was used to test the hypoglycemic biological activity of mulberry extracts 70 and lotus extracts 71 using a paper-based analytical device (PAD). Another researcher immobilized xanthine oxidase on a PAD 69 and measured the xanthine oxidase inhibitory activity of S. miltiorrhiza extracts. Therefore, paper-based microarrays can be used for the rapid quality detection of natural products, intermediates, and preparations.

Biomarkers have been used as drug quality indicators to evaluate the biological parameters of formulations. A high-quality biomarker should reflect the mechanism of action of the drug and be clinically relevant. In one study, a chip-based method was proposed to evaluate the bioconsistency of natural products using target enzymes thrombin and ACEs as quality biomarkers. A dual-channel microfluidic chip was designed to perform bioassays 72 , where enzyme complex formation occurs in one channel and the subsequent enzymatic reaction occurs in the other channel. Magnetic beads serve as both an efficient surface for immobilizing enzymes and a controllable solid support for enhanced on-chip mixing and transport. Enzyme activity is used to indicate drug quality (or potency). In Qishen Yiqi Pills, different batches of intermediates and preparations were tested, and the results showed that the bioassay had better discriminatory power for abnormal samples than chromatographic fingerprinting.

3.2.4. Biological soft sensing technology for intermediate product analysis

Most researchers have focused on the relationship between chromatography/mass spectrometry and biological activity of natural products, whereas the relationship between spectrum and activity has often been ignored.

Near-infrared reflectance spectroscopy (NIRS) was used to detect the anti-inflammatory activity of chrysanthemum extracts 74 . This work used NIRS combined with anti-inflammatory activity data. A complex relationship between Q-markers and overall anti-inflammatory activity was established by introducing backpr-opagation-artificial neural network. Thus, the comprehensive approach based on NIRS can quantify multiple compounds and predict overall biological activity for drug quality control. However, network toxicology or even bioinformatics alone can make the prediction, and the results should be verified by further experiments.

4. Application of biotechnology in pharmaceutical products analysis

4.1. safety analysis.

Efficacy and safety are two aspects of the properties of a drug when considering its use in disease treatment. It is necessary to consider the adverse reaction (including toxicity and side effects) of drugs when they are used. Toxicity evaluation usually comprises analyses of drug metabolic distributions, physicochemical properties, and pharmacokinetic characteristics such as genotoxicity target and organ toxicity. New drugs (including natural products and synthetic pharmaceuticals) have emerged, with rising safety problems. Traditional drug safety analysis techniques and methods can no longer meet growing needs, which requires an establishment of fast and accurate drug safety analysis techniques. Here, the progress of biological techniques used in the analysis of drug safety is summarized ( Fig. 5 ).

Overview of biological techniques used in drug safety evaluation.

4.1.1. Drug toxicity prediction based on bioinformatics

The concept of network toxicology is an important method for biopharmaceutical research developed by network pharm-acology 95 . Network toxicology of TCM refers to the study of the toxicological characteristics of a network model and analyzes the interaction and regulation of toxic materials in biological systems by the established network model, which plays an important role in predicting TCM toxic components 95 , 96 . Network toxicology refers to the description of the toxicological characteristics of drugs by constructing a specific network model to analyze and predict drug toxicity, thereby elucidating the toxic side effects of the drug on the human body and predicting the toxic components of natural products. Network toxicity is usually combined with other methods to detect drug toxicity. Network toxicity based on metabolomics has been used in toxicity mechanism analysis of TCMs 97 . For instance, the integration of toxicology networks and metabolomics was used to detect the metabolites in rat liver induced by esculentoside A, a triterpenoid saponin from Phytolacca acinosa 98 . However, network toxicology or even bioinformatiocs only can make the prediction, and the results should be verified by further experiments.

4.1.2. Drug toxicity analysis based on whole animal

Animal models are used to assess and avoid risk to humans from exposure to potential hazards. The pharmacopoeia suggests that drugs be tested by comparing with digitalis minimum lethality in pigeon 99 . Traditional animals, such as rats and mice, are commonly used animal models for drug toxicity analysis. However, the experimental animal models used in preclinical studies poorly predict drug metabolism and potential toxicity.

4.1.2.1. Transgenic animal analysis techniques

Transgenic or gene editing mice expressing labeled proteins and optical biosensors show potential for the analysis of disease etiology, pathogenesis, and the rapid large-scale screening of drug toxicity in preclinical studies 100 . The generation of available transgenic mouse models for long-term tracking of organelles, cells, or tissues is essential in drug toxicity analysis. Transgenic mice, such as human leukocyte antigen (HLA) mice lines and human liver chimeric mouse models, have rapidly developed over the past decade 101 , 102 . Abacavir, a human immunodeficiency virus reverse transcriptase inhibitor, and its drug reactions are highly associated with HLA alleles. Abacavir-induced liver injury was usually observed when HLA mice were treated with CpG-oligodeo-xynucleotides 103 .

Transgenic or gene-edited mice promote drug toxicity analysis, but this analysis requires huge workload and incurs high costs. Mouse models occasionally cannot meet the requirements of drug phenotypic screening. For example, thalidomide, which can induce birth defects in unborn children, does not cause any defects in mice 104 . For more comprehensive and cost-effective evaluation of drug safety, some new models have been established and more are emerging.

4.1.2.2. Disease animal model analysis techniques

Traditional animal models such as rats and mice involve high cost and long life. Therefore, alternatives to mammals for toxicology studies are warranted. With its ease of husbandry, high fecundity, small size, rapid production, development, and transparency, the young zebrafish ( Danio rerio ) shows potential as a model organism for detecting drug toxicity and toxicity mechanisms in vivo . The ability of in vivo screening coupled with the relevance of phenotypes to human diseases has contributed to the emergence of zebrafish as a leading model organism for whole-animal drug toxicity 105 , 106 . Fructus Psoraleae, the seed of Psoralea corylifolia , shows hepatotoxicity, and its potential hepatotoxic mechanisms were investigated in a zebrafish model 107 . The cardiotoxicity of four typical macrolides—azithromycin, clarithromycin, tilmicosin, and tylosin—was studied in zebrafish embryos 108 . The brain mitochondrial toxicity of Bacopa monnieri (Brahmi), traditionally used as a nootropic agent, was also analyzed in zebrafish 109 .

Caenorhabditis elegans is a small, non-pathogenic nematode with a short lifespan. Low-cost maintenance, easy cultivation, and efficient reproduction make this nematode suitable for rapid developmental toxicity testing. C. elegans assays were first used as a biological model and in environmental and chemical toxicity to obtain data from a whole animal with active digestive, reproductive, sensory, and neuromuscular systems 110 , 111 . Nowadays, this model is used in drug toxicity analysis, such as cisplatin 112 and aesculin, a coumarin compound extracted from TCM Qinpi (Cortex Fraxini) 113 .

4.1.3. Drug toxicity analysis based on cell biological techniques

Cell morphology is altered or damaged by drug toxicity, which are phenotypically categorized based on morphological characteristics. Tissue staining has been used for pathological screening in traditional toxicological analyses, but it cannot be used to observe organelle ( i.e. , endoplasmic reticulum, cytoskeleton) damage or reveal the mechanisms of endogenous molecular regulation caused by toxic drugs 114 . Although the tissue staining experiment is still required to detect drug toxicity, more cell biological techniques have been used.

Immunofluorescence is an important technique used in the diagnosis of many infectious diseases by detecting and localizing the antigens in different tissues and cells 115 . A near-infrared fluorescent probe was reported to evaluate hydrazide-induced liver injury by detecting the N 2 H 4 level 116 . Flow cytometry is used for counting, analyzing, and sorting cells in a cell suspension by their light-absorbing or fluorescing properties. It permits the assessment of physical (cell size, shape, and internal complexity), chemical (expression of proteins and other molecules), and biological attributes of single cells in the suspension 117 . Flow cytometry techniques can be used for measuring the morphological effects of both natural products 118 and synthetic pharmaceuticals. It is usually used to analyze cytotoxicity induced or repressed by drugs. For instance, ginsenoside Re inhibited rot-induced cytotoxicity in SH-SY5Y cells in Drosophila could be measured by flow cytometry 119 .

Cell biological techniques are the fastest and most convenient analysis techniques of drug safety, but they are also limited by cell lines and states. Sometimes, cells are easily contaminated; thus, a sterile environment is required.

4.1.4. Drug toxicity biomarker analysis based on high-throughput techniques

The formal qualification of safety biomarkers is a milestone in the application of biomarkers to drug development. Biomarkers significantly contribute to new drug development because they facilitate drug toxicity assessment. With the development of high-throughput sequencing technologies or omics, drug toxicity analysis is promoted, especially to identify biomarkers.

Toxicogenomics is a branch of toxicology that applies several genomic analysis techniques to determine how chemicals, both environmental and pharmaceutical agents, react on human and ecological health 120 . It includes the identification of organisms associated with disease and toxic biomarkers. Equipped with innovative technologies from genomics and high-throughput methodologies, toxicogenomics provides an unprecedented opportunity for improved risk assessment and regulatory decision making.

The ability to screen numerous molecules ( e.g. , metabolites, proteins, or DNA) allows the identification of toxicity biomarkers, which may be used to enhance drug safety assessments and disease diagnostics. Different from measuring a single molecule at one time, high-throughput profiling simultaneously screens thousands of molecular changes. Transcriptomics or gene expression profiling measures the changes in transcript levels and reflects gene expression regulation at transcriptional and post-transcriptional levels. Vine tea is made from the tender leaves of Ampelopsis grossedentata , and its chemical composition is mainly flavonoids and polyphenolic substances with dose-related hepatotoxicity. Transcriptomic profiling revealed 34 potential toxic components and 57 potential hepatotoxic targets in vine tea 121 . Meanwhile, proteomic profiling measures the changes in protein levels and reflects the regulation of gene expression, protein translation, and post-translational protein stability 122 . The toxicities of Herba Lysimachiae (Jinqiancao), which is usually used to treat rheumatic arthralgia, were analyzed by proteomic profiling 123 . With DARTs-based proteomics, the potential toxic target of psoralen, a major hepatotoxic and blood entry component in Fructus Psoraleae, was identified 124 . Metabolomic profiles determine molecules acting as intermediates and metabolic products and identify hormones and other signaling molecules in many biological processes 125 . Heshouwu ( Polygonum multiflorum ), a famous traditional Chinese herb, is associated with significant liver injury 126 . Toxic components related to the drug-induced liver injury of Heshouwu and specific biomarkers were investigated using the UHPLC–MS-based metabolic approach 127 . Anthraquinone, which belongs to polycyclic aromatic hydrocarbons, is the main active component in Cassiae semen (Juemingzi) and shows toxic reactions. The established urinary metabolomics approach allowed the determination of aurantio-obtusin biomarkers for the early diagnosis of its toxicity 128 . Thus, the biomolecular coverage provided by omics profiling can be used to improve the performance of traditional toxicity prediction methods.

4.2. Effectiveness analysis

Early and effective pharmaceutical analysis methods are of great significance in the biotechnology and pharmaceutical industries. The purpose of drug quality evaluation and control is to ensure clinical efficacy and safety. Although the quality standardization of natural medicines and synthetic drugs has made significant progress in biochemical research 129 , its guiding or supporting role in the rationalization of clinical medication and improvement of clinical efficacy needs to be studied further.

Bioassays have become one of the most important development directions of drug quality standardization because of their technical advantages of efficacy-related properties and overall control 130 To evaluate the efficacy-related biological effects expressed by test drugs acting on the biological model (whole animals, isolated organs and tissues, cells, biology-related factors, and enzymes) under specific conditions, bioassays have been used for the qualitative or quantitative evaluation of drugs 131 , 132 , 133 ( Fig. 6 ).

Bioassays in effectiveness analysis.

Several related studies have been performed in the effectiveness analysis of both natural medicines and synthetic drugs. For instance, the rat bile duct ligation model was established to evaluate the anti-hepatic fibrosis effect 134 , the NRLP3 inflammasome activation model was constructed to determine the anti-inflammatory function 135 , and thrombin activity was used to assess the anticoagulant response 136 of drugs. Many promising cutting-edge techniques, such as biosensors, organ-on-a-chip (OOAC), and 3DP, have been developed for pharmaceutical analysis ( Fig. 6 ). By using these biotechniques, bioassays can be more efficiently and accurately developed for pharmaceutical analysis.

4.2.1. Target-based biosensors for effectiveness analysis

Biosensors are bioanalytical devices developed by integrating electronic techniques and biological molecules or systems. They hold promise in the analysis of various drugs because of their high sensitivity and low cost 137 . The discovery of taste type II receptor (TAS2R) agonists is valuable for treating asthma, but the development of a fast screening method to identify TAS2R agonists is challenging. Inspired by the advantages of the high-electron-mobility transistor (HEMT) sensor, Wang et al. 144 developed a virtual and affinity screening strategy based on the combination of a HEMT biosensor with UPLC–MS analysis to screen TAS2R14 agonists from Platycodon grandiflorum . They obtained six potential TAS2R14 agonists, with platycodin L as a special TAS2R14 agonist. This study provided a strong reference for the direct screening of agonists or inhibitor classes of drugs from complex natural medicines 138 . In addition, using the ligand-induced conformational changes in G protein-coupled receptors (GPCRs) as the basis, Dong et al. 139 designed a 5-HT2AR-based fluorescent biosensor termed psychLight to detect endogenous serotonin release. This sensor identified previously unknown hallucinogenic drugs and a non-hallucinogenic psychedelic analog with neural plasticity-promoting and antidepressant properties. This study provided insights into the early identification of designer drugs of abuse and the development of 5-HT2AR-dependent non-hallucinogenic therapeutics. Given the critical selectivity of GPCRs on ligands, such biosensors can be used to monitor the active components and their holistic potency of natural products in a target-based way, namely, target-based drug potency. Therefore, biosensors can be used to analyze and assess the quality of natural products with multiple components 140 . Because of the direct association of dopamine and uric acid in human blood serum with human emotional and physical health, the simultaneous detection of both chemicals is important for the early diagnosis and treatment of related diseases. Gong et al. 141 developed a low-cost high-entropy porous CrO/CrN/C biosensor for simultaneously determining dopamine and uric acid in human serum samples. The high-density distribution of catalytic CrO/CrN nanoparticles in porous Cr-JFC/DAC2 composite provided the high surface, abundant crystal interface, and excellent conductive properties of the Cr-JFC/DAC2/Nafion/GCE bio-sensor. Under optimum conditions, the biosensor could simultane-ously detect dopamine and uric acid in the range 0.05–4 μmol/L with limits of detection of 10.65 and 17.54 nmol/L, respectively. Chen et al. 142 designed a cotton thread-based multi-channel photothermal biosensor for the simultaneous detection of three breast cancer-related miRNAs, namely, miRNA-10b, miRNA-27a, and miRNA-let-7a. The biosensor has high specificity and sensitivity with the detection limits of 37, 38, and 38 pmol/L for the three miRNAs. In addition, its application in cell lysates indicated the excellent capacity of the developed multi-channel photothermal biosensor for the practical analysis of multiple targets.

4.2.2. 3D biological printing of organoids for personalized pharmaceutical analysis

As a 3D cell culture, the organoid is a physiologically relevant model for basic and clinical applications and presents a self-organizing, self-renewing, and more physiologically relevant model than conventional 2D cell cultures, thus opening new avenues for drug testing and the development of therapeutic approaches in a pre-clinical setting 143 . Patient-derived organoids exhibit several advantages as personalized tumor models and can be established in a short period with low cost for the identification and testing of new anticancer drugs. Schuster et al. 144 developed an automated microfluidic organoid culture platform for dynamic and combinatorial drug screening, thus enabling the highly reproducible, dynamic, and robust analyses of organoids with potential to facilitate treatment decisions for personalized therapy.

As one of the most progressive innovations in pharmaceutical science, 3DP has become a revolutionary and powerful tool in the precise manufacturing of individually developed dosage forms, tissue engineering, pharmaceutical analysis, and disease modeling 145 . It allows a fast, efficient, and economical production of customized drug carriers with desirable shape, size, and structure from 3D computer data to provide personalized medication, various drug combinations, and complex drug release profiles. Diverse 3DP technologies include binder jetting, fused deposition modeling, pressure-assisted microsyringe, inkjet printing, vat photopolymerization, and selective laser sintering, which have been developed in drug and medicine research 146 . Using acrylic acid (AA) as a monomer, poly (ethylene glycol) dimethacrylate as a difunctional crosslinker, and acrylated hyperbranched polyester (AHBPE) as a multifunctional crosslinker, Chen et al. 147 produced 5-fluorouracil-loaded tablets using digital light processing 3DP. They found that the printing time and drug release increased with AA content but decreased with increasing AHBPE content. In addition, they suggested the use of AHBPE as a crosslinker in vat photopolymerization 3DP of personalized drug delivery.

The effective recapitulation of the structure and function of tissues as organoids can help predict patient response for precise drug screening and further personalized drug validation and therapy in a timely manner 148 . For example, because patient-derived tumor organoids allow a highly cellular repository to recapitulate the essential characteristics of the original native tumors, they can be used as superior models for identifying and testing anticancer drugs or natural medicines 149 . To determine the effective drugs to treat glioblastoma, the most common and deadly primary brain malignancy, Chadwick et al. 150 generated 4D cell culture arrays by 3DP with thermo-responsive shape memory polymer for rapid assessment of drug responses in glioblastoma patient-derived organoid-like models. They evaluated drug sensitivity, on-target activity, and synergy in drug combinations. The platform is beneficial for rapid functional drug assessments for future selection of more effective personalized therapies. Curcumin, a polyphenol compound derived from the stems of Curcuma longa , is effective in suppressing various phases of colorectal cancer (CRC) development. Chen et al. 151 designed patient-derived organoids of colorectal cancer and developed a non-targeted metabonomic technique to evaluate the inhibitory effect and mechanism of curcumin on CRC organoids. This study provided a strong reference for curcumin as a potential natural drug in treating human-derived CRC-like solid tumors.

4.2.3. Microfluidic-combined OOAC for high simulation pharmaceutical analysis

OOAC mimics the physiology and functionality in human organs on a chip and has been claimed to foster a paradigm shift in drug testing and development 152 . It is constructed with the silicon-based organic polymer polydimethylsiloxane and has a compact size and various microchannels for early drug discovery and preclinical screening and testing. Ren et al. 153 reported a “heart-on-a-chip” platform that combines microgrooves and electrical pulse stimulation to recapitulate the well-aligned structure and synchronous beating of cardiomyocytes, which could provide a high-throughput drug screening platform for preclinical drug development. A bioartificial liver consisting of a surface-engineered microfluidic silicon chip with microtrenches mimicking hepatic sinusoids has also been reported 154 . This artificial liver model can extend 3D primary hepatocyte culture. It allows reliable prediction of in vitro responses, including drug responses and environmental stimulus responses. It has potential applications in various fields such as drug discovery and toxicity testing, and basic pathology and physiology research 155 , 156 . Currently, a more advanced “body-on-a-chip” or “human-on-a-chip” platform simulates the physiology of the entire human body, which can serve as an alternative model system to replace animal models in drug development and analysis. However, because of the complexity of the human system, some technical challenges should be addressed in the future 157 .

Microfluidic chip, also known as “laboratory-on-a-chip”, is a rapidly growing versatile technology that precisely manipulates nanoliter volumes (10 −9 to 10 −18  L) of fluids in microchannels. With distinctive features of low consumption of reagents, fast mixing, large specific surface area, high mass, short diffusion distance, and rapid actuation and response, this technology is a powerful tool for pharmaceutical analysis from drug synthesis to drug delivery to drug evaluation 158 . For example, Huang et al. 159 constructed an arrayed geometrically enhanced mixing chip with individual function zones to quickly and accurately evaluate the potency of five drugs. In addition, with the rapid development of digital manufacturing techniques, 3DP-assisted microfluidic chip devices have proved advantageous in improving the efficiency, speed, and control of pharmaceutical analysis 160 .

Microfluidic OOAC systems provide unparalleled independent control over multiple key biological, chemical, molecular, cellular, and mechanical parameters within the intestinal microenvironment, thereby enabling researchers to apply a synthetic biology approach at the cell, tissue, and organ levels that can lead to new insights into intestinal physiology and disease mechanisms. For example, “intestine-on-a-chip” can be used to analyze the molecular processes underlying various enteropathies and to advance the development of new therapies 161 .

4.2.4. Omics-based AI for drug effectiveness analysis

AI technology provides opportunities for the design, discovery, and development of innovative drugs in different areas, from peptide synthesis to molecule design, virtual screening to molecular docking, and quantitative structure–activity relationship to drug repositioning 162 , 163 . It mainly includes deep learning and machine learning algorithms for the identification and validation of chemical compounds, target identification, drug monitoring, and drug efficacy and effectiveness assessment 164 , 165 . By exploring the capacity of AI to predict the activity of various synthesized molecules, Polykovskiy et al. 166 demonstrated that AI not only improved procedural accuracy and efficiency but also enabled drug discovery. Although tremendous amount of work is required to incorporate AI tools in the pharmaceutical analysis cycle, it is thought that AI technology will bring revolutionary changes in innovative drug discovery and analysis processes. For example, by combining chemical fingerprint and bioactivity evaluation of S. miltiorrhiza using AI technology by introducing intelligent chemometric methods, the possible antibacterial components of this natural medicinal plant on Pseudomonas aeruginosa was rapidly and effectively explored 167 . The AI-assisted fingerprint–activity relationship can act as a powerful bioassay model to identify the bioactive components in natural medicines for omics-based pharmaceutical analysis and quality control.

AI technology can improve the efficiency and accuracy of drug discovery and development, which not only enhances process efficiency but also reduces or eliminates the requirement for clinical trials by conducting simulations, reducing costs and ethical concerns, and heralding a new age for pharmaceutical analysis.

4.3. Quality controllability analysis

Some biotechnologies have been explored in drug quality evaluation due to their advantages in reflecting the overall biological effects of drugs, reflecting the drug quality related to its function, and providing visual and intuitive results. Biological detection methods are the core evaluation methods to study the effectiveness and safety of drugs as well as quality evaluation. For drug quality analysis, there are higher requirements for the sensitivity, accuracy, and throughput of techniques compared with techniques for pharmacological or toxicological research methods. Based on the biological effects of drugs, biotechnologies such as gene/enzyme/cell model organisms, microfluidic chips, and electronic tongues have been used to evaluate the quality of drugs from the perspective of activities to achieve the goal of controlling or evaluating drug quality related to its function. Some representative biological evaluation methods are described in Fig. 7 .

Biotechniques for pharmaceutical quality control analysis.

4.3.1. Molecular authentication for formulation analysis

DNA barcoding technology is a technique that uses standard DNA sequences (200–600 bp) as species identification markers, and usually requires DNA extraction, PCR, sequencing, and sequence analysis steps. Compared with macromolecular techniques such as protein or RNA, the DAN barcoding technique is more stable and accurate. This method has been widely used for the species identification of raw materials of natural products. However, it is difficult to obtain complete DNA barcodes from preparations of natural products because of DNA degradation, at which point DNA mini-barcoding comes into the picture. Compared with DNA barcoding, DNA mini-barcoding uses shorter DNA lengths (<200 bp), which can achieve more efficient extraction and amplification 168 , 169 . DNA mini-barcoding broadens the application of DNA barcodes and is suitable for evaluating the quality of natural product preparations. An adaptor ligation-mediated PCR protocol was derived to amplify sets of target DNA fragments isolated from Angelica sinensis and Panax notoginseng 170 . DNA extracted from A. sinensis and P. notoginseng were ligated with adaptors and amplified by an adaptor primer and a single universal barcode primer to avoid amplification of non-target DNA sequences and obtain partial ITS2 sequences. The results showed that various lengths of DNA fragments within the ITS2 region were amplified and could be used to identify the concerned species. Liu et al. 171 developed a rapid identification method using the RPA assay to detect two species, Ginkgo biloba and Sophora japonica (as adulteration), in Ginkgo folium products. The short region in the ITS2 sequence was amplified to identify S. japonica and the short region in the rbcL sequence was amplified to identify G. biloba . During the authentication process, the RPA-LFS assay showed a higher specificity, sensitivity, and efficiency than PCR-based methods, demonstrating that this assay can be developed into an efficient tool for the rapid on-site authentication of plant species in G. biloba herbal products.

DNA metabarcoding is a technique that uses universal PCR primers to simultaneously amplify multiple DNA barcodes and identify multiple species in a single environmental sample 172 . Metabarcoding and single-molecule, real-time (SMRT) sequencing was used to detect the multiple ingredients in Jiuwei Qianghuo Wan 173 , and the results showed that with the combination of metabarcoding and SMRT sequencing, it is repeatable, reliable, and sensitive enough to detect species in TCM products. Han et al. 174 developed a nucleotide signature based on an SNP site unique to American ginseng and 4F/4R unique to ginseng were designed. Twenty-four batches of ginseng products in Chinese patent medicines marketed in Beijing were tested, and five batches were counterfeit products and two batches were adulterated products. Thus, nucleotide signatures broadened the application of DNA barcoding technology in the identification of ginseng products. The method can rapidly identify ginseng products. Ririe et al. 175 introduced melting curves into DNA analysis in the 1990s. The technique uses melting curves of several species and avoids sequencing. The principle of barcoding high-resolution DNA melting (Bar-HRM) 176 is as follows. The double-stranded DNA used in PCR is bound to a dye. Although the fluorescence is intense when bound to the dye, the fluorescence level is low when released. After PCR, 50–500-bp-long amplicons are gradually denatured by a small temperature increase of 0.01–0.2 °C, and the fluorescent dye is slowly released from the denatured amplicons. The diminishing fluorescence with increasing temperature can be plotted as a melting curve. Bar-HRM has been used to analyze herbal material products such as Rhizoma Paridis 177 .

4.3.2. Electronic tongues for pharmaceutical formulation analysis

The term “electronic tongue” simulating the human gustatory system was first reported in 1996 178 . Electronic tongues are devices consisting of arrays of low-selective sensors and using advanced mathematical procedures for signal processing based on multivariate data analysis, principal component analysis (PCA), pattern recognition, and artificial neural networks (ANNs) 179 . A large number of chemical sensors were used in the design of electronic tongue sensor arrays 180 . Specifically, the electronic tongue system has been used for pharmaceutical analysis, such as the investigation of taste-masking efficiency, dissolution measurement, and quality control of drugs, herbal medicine, and medicinal plants for batch-to-batch product reproducibility and determination of active pharmaceutical ingredients (APIs) 181 , 182 .

New drug formulations and dosage forms are constantly being introduced with novel pharmaceutical technologies. Artificial sensing systems were thus developed as supplementary analysis methods for pharmaceutical formulations 180 . Weitschies et al. 183 used a commercial taste-sensing device (TS-5000Z) to evaluate the different taste-masking strategies. The taste-masking efficiency of cyclosporin A (CyA) loaded self-emulsifying drug delivery system and orally disintegrating tablets was evaluated by the α -Astree electronic tongue 184 . Winnicka et al. 185 reported a prototype of an electronic tongue for the comparison of microparticles, lyophilisates, and orodispersible tablets loaded with dihydrochloride cetirizine. The taste profiles of three diclofenac drug formulations could be differentiated using electronic tongues 186 . The Euclidean distances on the PCA plot were highly correlated ( R 2  = 0.986) with the bitterness intensities of the chemical signals of formulations of different brands 187 .

The electronic tongue systems were also used to differentiate quality variation in natural product preparations. Shakaff et al. 188 developed a multichannel sensor incorporated with an array of the artificial lipid polymer membrane as a fingerprinting device for quality analysis of extracts from different parts, age, batch, and extraction mode of Eurycoma longifolia , with the obtained potentiometric fingerprint profiles. Various taste-masking methodologies and electronic tongue techniques were used in pharmaceutical analysis 189 , 190 , 191 . However, the benefits and drawbacks of electronic tongues for pharmaceutical applications are hardly evaluated because of the variance in the principle of chemical sensors and data processing methodologies. Therefore, the reliability of two commercially available systems (from Insent and AlphaMOS) and four laboratory prototype systems were used for the analysis of the same set of pharmaceutical samples under blind conditions 192 .

As an emerging and promising analysis tool in the area of pharmaceutical products, the electronic tongue has proved to be an important technology to assess and predict the taste of APIs in the pre-clinical development of pharmaceutical candidates as well as to promote the rational design of oral taste-masked dosage forms 186 .

4.3.3. Reporter gene transfected cell-based and enzyme-based quality analysis

Reporter genes encode proteins or enzymes that can be easily detected in the context of endogenous proteins 193 . Specifically, a reporter gene is connected with a target gene or regulatory sequence. The activity of the coding product of the reporter gene directly reflects the transcriptional activity or expression level of the gene in the cell 194 . The firefly luciferase reporter gene is a commonly used reporter gene in mammalian cells. Luciferase has high sensitivity and a wide linear detection range of 7–8 orders of magnitude. The enzyme activity can be detected by fluorescence colorimetry; thus, it is suitable for high-throughput screening with high accuracy. It has been gradually recognized and applied in the quality control of herbal medicines.

Professor Cheng's laboratory has established a series of cell lines transfected with luciferase reporter genes related to hormone, endocrine, immune, and inflammation signal pathways, and applied them to the quality evaluation of single herbal medicines 195 and formulation yiv-906 196 , a standardized four-herb formula from a traditional formula “Huang Qin Tang” for some gastrointestinal symptoms, including diarrhea, nausea, and vomiting. This method realizes the purpose of distinguishing yiv-906 and commercial Huangqin Tang preparations, although yiv-906 and commercial Huangqin Tang preparations could not be differentiated with the chemical profile based on LC–MS fingerprints with 77 peak intensities. Therefore, this combined biological evaluation method has more distinguishing ability than the LC–MS fingerprinting method, although LC–MS has high resolution and sensitivity. At the same time, this evaluation method is highly related to the results of pharmacological evaluation in vivo and can reflect the action mechanism of yiv-906. Therefore, this method is also called mechanism-based quality control (MBQC). In addition, enzyme activity assay related to hormone, endocrine, immune, and inflammation signal pathways were used in this MBQC platform 195 , 196 . Chao et al. 197 used ER- α promoter and nuclear factor erythroid-2-related factor (Nrf2) promoter transferred cell lines and COX-2 enzyme inhibitor screening assay to evaluate the quality of Uraria crinita processed by three drying methods and different temperatures. The bioassay showed that the biological activity of U. crinita oven-dried at 40 °C was the best, which was confirmed by chemical profile analysis that the main active component content in U. crinita oven-dried at 40 °C was the highest. These bioassays could be used to assess the effect of drying temperature on U. crinita quality. Cell lines stably transfected with luciferase reporter genes related to AP-1, TLR2, ER- α , Nrf2, and AR signal pathways were used to compare different processed Ephedrae Herba 198 and Astragali Radix 199 , and this method can significantly distinguish different processed products. These studies show that bioassays can be used to evaluate differences in quality caused by different processing methods.

Reporter gene assays are suitable for high-throughput analysis with high accuracy and sensitivity, but their repeatability may be affected by the state of transfected cell lines and it is not easy to establish the reference material as a positive control. Furthermore, the bioassay based on the luciferase reporter gene-transfected cell line or enzyme is related to the action mechanism of the drug on signal transduction pathways. The selection of luciferase reporter genes or enzymes can reflect the actual drug efficacy in vivo , which may be a combination of different biological activities for TCM with multiple functions.

4.3.4. Holistic organism-based quality analysis

Compared with cell lines or enzymes, holistic organisms are intact living organisms that can reflect the synergistic effects of a drug on different parts of an organism to determine its actual quality. Compared with mammals used for conventional pharmacological evaluation, these model organisms are relatively convenient. Therefore, model organisms are routinely used in pharmacological studies and have gradually been introduced to exploratory studies of drug quality evaluation.

The most widely used model organisms in health studies include zebrafish, C. elegans , Drosophila , E. coli , and Saccharomyces 200 , 201 , 202 , 203 . In the last decade, large-scale genome sequencing has revealed that human genes are 61% similar to those of Drosophila , 43% similar to those of nematodes, and 46% similar to those of Saccharomyces . As an emerging model organism, zebrafish has a high genomic sequence similarity of 87% to humans 204 , and it has several biological advantages such as in vitro fertilization, embryonic transparency, and easy observation of tissue and organ development under the microscope without dissection 205 . Experiments can be performed in cell plates, thus requiring a small amount of samples. Therefore, this model has been recommended as a new alternative animal by the European Centre for the Validation of Alternative Methods 206 , 207 . As a whole animal model, the zebrafish has unique advantages in the screening of pharmacodynamic substances and evaluating the quality of natural drugs with complex composition and unclear pharmacological mechanisms. It may realize the convenient, rapid, and high-throughput screening of pharmacodynamic substances of TCM and establish their biological quality evaluation standard.

Zebrafish larvae with arachidonic acid (AA)-induced thrombus was used to evaluate the antithrombotic effects of Xuesaitong injection (XST) from different batches 208 . The results indicated that XST could significantly and dose-dependently restore the intensity of heart red blood cells in thrombotic zebrafish but decreased red blood cell accumulation in the caudal vein. Using the zebrafish thrombosis model, five abnormal batches of XST were effectively distinguished from 24 normal batches of XST. This finding was confirmed by conventional chemical methods. Therefore, this zebrafish thrombosis model can be used for the batch-to-batch consistency evaluation of XST. Quality-marker (Q-marker) is an emerging concept to evaluate TCM quality that aims to screen marker compounds that fully reflect the “five principles” 104 . Li et al. 209 identified the potential Q-markers of Danhong injection (DHI) using an in vivo zebrafish thrombosis model for batch-to-batch quality consistency evaluation. The results showed that rosmarinic acid and p -coumaric acid, the main chemical components of DHI, showed moderate antithrombotic effects in a dose-dependent manner and could be used as potential Q-markers to evaluate the quality consistency of DHI. Gao et al. 210 also examined the antithrombotic activity of Hawthorn leaf fractions by platelet aggregation assay and a zebrafish model for antithrombotic drugs. Combined HPLC–QTOF-MS and molecular modeling identified shadyside D and norhawthornoid B as key components in inhibiting platelet aggregation mainly by acting on the targets of key regulators of antiplatelet aggregation activity (P2Y1 and P2Y12).

C. elegans has also been used in drug quality evaluation. Ping et al. 211 evaluated the effect of Ganoderma lucidum water extracts on oxidative stress resistance, including the five origins of G. lucidum from wild-type and forkhead box O transcription factor mutant, using C. elegans . The results showed significant differences in the effect of G. lucidum on improving resistance to oxidative stress and in the mechanisms by which different origins of G. lucidum improve the ability of nematodes to oxidative stress. This finding suggested the presence of different potent active substances in different origins of G. lucidum and proved that the use of the model organism C. elegans could effectively distinguish the biological activities of G. lucidum from different origins.

4.3.5. Biologically microfluidic technologies based-quality control methods

The microfluidic chip or micro total analysis system (uTAS) is a new technology that integrates sampling, pretreatment, reagent addition, reaction, separation, and detection on a microchip. This technology has the advantages of small size, simple operation, low sample usage, fast analysis, and easy automation of operation 212 , and it can be used to perform chemical separation and enzyme and cell analyses 213 , 214 , 215 . The integration of microfluidic chip and enzymes or cells may improve the repeatability of bioassays. Microfluidic chips have been rapidly developed and used in drug quality evaluation. Ho et al. 216 developed a device that can quantify the API content in antimalarial drugs to evaluate their quality. The system consists of two parts, a detection reagent (probe) and a microfluidic platform, and is based on the luminol reaction between the probe and API. Pure and unqualified samples of artesunate (Arsuamoon tablets) were detected using this system, and the accuracy of the quantitative method was confirmed in comparison with the conventional 96-well plate spectrophotometric method. Li et al. 72 reported a multiplex biomarker assay for assessing drug quality using the combination of microfluidics and enzymes. In this study, thrombin and ACE were used to evaluate the quality of Qishen Yiqi Pill. Potency variations were detected in different batches of intermediates and preparations of Qishen Yiqi Pill. The results showed the feasibility of using microfluidic technology for the quality evaluation of Chinese pharmaceutical preparations.

OOAC is more accurate than traditional cell-based models and is expected to replace the animal phase of drug testing to significantly reduce the time and cost of drug development. Researchers have demonstrated a fluid-coupled two-channel microfluidic human OOAC model of the intestine/liver/kidney 205 . The model provides the pharmacokinetic parameters of drug absorption, metabolism, and excretion in humans and predicts pharmacokinetic parameters for oral nicotine and intravenous cisplatin. With further development, this technology can be used to create chips with the combination of different organs to achieve rapid and high-throughput analysis of drugs for quality evaluation ( Table 3 ).

Application of biotechnology in pharmaceutical product analysis.

5. Summary and prospects

Biotechnology approaches are as important as physical- and chemical-based detection techniques because they can provide information on biological activity and even clinical efficacy and safety of a drug. Chemical technology and biotechnology have their pros and cons: botanicals with identical chemical spectrum may display different biological activities when bioactive constituents cannot be detected under analytical conditions, and botanicals with different chemical profiles may have the same bioactivity when the phytochemicals responsible for the difference are biologically inert. In the future, biotechnology together with chemical and physical analyses should participate in the whole life cycle of drug quality control.

Bioanalysis is important for pharmaceutical analysis and has been widely used in different areas of pharmaceutical analysis, including qualitative analysis of drugs such as species identification based on herbgenomics 219 , drug safety analysis such as pesticide residue detection, and effectiveness evaluation such as biological evaluation. Biotechnology has the advantages of high sensitivity and specificity, but its popularization is often limited by the complex operations and high costs. It also has the problems of poor repeatability and false-positivity, requiring much research for optimization and improvement.

At present, bioanalytical technology is applied more to biological drugs and less to natural product and synthetic drugs. This might be because most researchers in the field of pharmaceutical analysis have a background in chemistry. The importance of bioassays and their applications are ignored in current pharmaceutical analysis. With the continuous development of basic biology and the subsequent improvement of bioanalytical methods, biotechnology can play a vital role in the overall quality control of natural products and synthetic pharmaceuticals.

Acknowledgments

We would like to thank TopEdit ( www.topeditsci.com ) for linguistic assistance during the preparation of this manuscript. This study was supported by the National Key R&D Program of China (No. 2019YFC1711100, China) and the National Natural Science Foundation of China (No. U1812403-1, China). The author would like to thank Dr. Jiabo Wang, Weijun Kong (School of Traditional Chinese Medicine, Capital Medical University, Beijing, China).

Author contributions

Shilin Chen conceived, supervised and reviewed the manuscript; Shilin Chen, Zheng Li, Sanyin Zhang, Yuxin Zhou, Xiaohe Xiao, Pengdi Cui, Binjie Xu, Yuntao Dai, Qinghe Zhao and Shasha Kong wrote the manuscript. Yuntao Dai conceived and reviewed the manuscript. All of the authors have read and approved the final manuscript.

Conflicts of interest

The authors declare no conflicts of interest.

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Plant Biology and Biotechnology: Focus on Genomics and Bioinformatics

Affiliations.

• 1 Agrarian and Technological Institute, Peoples' Friendship University of Russia, 117198 Moscow, Russia.
• 2 The Digital Health Institute, I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University), 119991 Moscow, Russia.
• 3 Institute of Cytology and Genetics SB RAS, 630090 Novosibirsk, Russia.
• 4 Department of Bioinformatics, College of Life Sciences, Zhejiang University, Hangzhou 310058, China.
• PMID: 35743200
• PMCID: PMC9223720
• DOI: 10.3390/ijms23126759

The study of molecular mechanisms of plant stress response is important for agrobiotechnology applications as it was discussed at series of recent bioinformatics conferences [...].

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• Trainings/Workshops
• Result notice of (Advertisement No. 01/2019/Consultant/HR) Recruitment for Consultant(Scientific & Technical)
• RCB PhD (Integrated) Degree Program 2020 MSc-PhD in Biotechnology
• 4th edition of Smart India Hackathon (SIH)-2020
• International conference on Calcium Signaling
• Recruitment for Academic Positions (Advt. No. Faculty/01/2019/Acad)
• Project Positions
• Bio-Incubator accepting proposals for incubation
• Recruitment for Academic Positions

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