Pharmaceutical Biotechnology (Theory)

• The objectives of this course are to:
• Understand and apply plant tissue culture techniques and related approaches for biomass and secondary metabolite production.
• Introduce biomanufacturing concepts in herbal drug technology, including plant-based production systems and edible vaccines.
• Develop skills in the preparation and optimization of standardized herbal extracts using metabolite analysis and TLC fingerprinting.
• Study the formulation of herbal products using standardized extracts in conventional and novel dosage forms.
• Understand quality control, standardization, regulatory guidelines, and interaction studies for safe herbal drug development.

After completion of the course student will be able to:

1. CO1Explain the role of biotechnology in pharmaceutical sciences, including monoclonal antibodies and enzyme immobilization.
2. CO2Apply genetic engineering and recombinant DNA technology for the production of biopharmaceuticals such as insulin, interferons, and vaccines.
3. CO3Describe microbial biotransformation and analyze fermentation processes used in pharmaceutical industries.
4. CO4Assess the role of bioinformatics and artificial intelligence in the Human Genome Project and personalized medicine.
5. CO5Describe vaccine and sera development, including preparation, evaluation, standardization, and regulatory requirements, and critically evaluate challenges and emerging approaches in vaccine and sera development and commercialization

1. Crommelin, D. J. A., Sindelar, R. D. and Meibohm, B. Pharmaceutical Biotechnology: Fundamentals and Applications. Springer.
2. Walsh, G. Biopharmaceuticals: Biochemistry and Biotechnology. Wiley-Blackwell.
3. Brown, T. A. Gene Cloning and DNA Analysis: An Introduction. Wiley-Blackwell.
4. Glick, B. R., Pasternak, J. J. and Patten, C. L. Molecular Biotechnology: Principles and Applications of Recombinant DNA. ASM Press.
5. Doran, P. M. Bioprocess Engineering Principles. Academic Press.
6. Vogel, H. C. and Todaro, C. L. Fermentation and Biochemical Engineering Handbook. William Andrew.
7. Primrose, S. B., Twyman, R. M. and Old, R. W. Principles of Gene Manipulation and Genomics. Wiley-Blackwell.
8. Strachan, T. and Read, A. Human Molecular Genetics. Garland Science.
9. Plotkin, S. A., Orenstein, W. A., Offit, P. A. and Edwards, K. M. Elsevier.
10. Kindt, T. J., Goldsby, R. A., Osborne, B. A. and Kuby, J. Kuby Immunology. W. H. Freeman.
11. Janeway, C. A., Travers, P., Walport, M. and Shlomchik, M. Immunobiology. Garland Science. Semester-IV Course Title Course Type