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BP408PSemester 41 creditsPractical

Pharmaceutical Biotechnology (Practical)

Complete unit-wise syllabus for BP408P as per the PCI B.Pharm NEP 2020 curriculum (Semester 4 — Medicinal Chemistry + 1st Internship).

URL:https://pharmacode.vercel.app/syllabus/semester-4/bp408p-pharmaceutical-biotechnology-practical/

Course Objectives

  • Provide fundamental knowledge of biotechnology concepts, including protein therapeutics, monoclonal antibodies, enzyme immobilization, and their pharmaceutical applications.
  • Explain the principles and applications of genetic engineering and recombinant DNA technology in pharmaceutical sciences.
  • Develop understanding of microbial biotransformation, fermentation processes, and large-scale production of pharmaceutical products such as alcohol, antibiotics, vaccines, and blood products.
  • Describe the principles, methodologies, delivery systems, and ethical considerations associated with gene therapy and modern vaccine technologies.
  • Introduce the regulatory requirements and standardization procedures for vaccines, sera, and other biopharmaceutical products.

Unit-wise Syllabus

1 Units
1
Laboratory Practicals & Experiments (45 Hours)45 Hours
  • 1. Understanding Good microbiological laboratory practices while working in Microbiology laboratory aseptic handling in microbiology lab: growth and isolation of microbes using streaking, spreading and subculturing techniques: microbial staining, study of various equipments such as loop, straight wire, spreader, forceps, pipette, test tube, petridish, burner etc and apparatus used in microbiology lab- BOD incubator, laminar flow, aseptic hood, autoclave, hot air sterilizer, deep freezer and microscopes.
  • 2. Handling of biological spill, decontamination procedures and hygiene while handling microorganisms and disposal
  • 3. Sterilization and evaluation of glassware and apparatus using hot air oven
  • 4. Preparation and sterilization of solid and liquid culture medium using different techniques
  • 5. Determination of microbiological efficacy of disinfectant/ preservative efficacy test
  • 6. Tests for sterility of ophthalmic or parenteral marketed formulation according to IP.
  • 7. Analysis of Biotechnological product (Protein, nucleic acid materials) by UV Vis and FTIR spectrophotometer
  • 8. Production of alcohol using Fermentation process
  • 9. Practice Whole cell immobilization technique (any one)
  • 10. Practice Enzyme immobilization technique and its kinetics
  • 11. Isolation and estimation of DNA and RNA
  • 12. Isolation of plasmids and expression of protein
  • 13. Agarose gel electrophoresis of DNA/ RNA
  • 14. SDS – polyacrylamide gel electrophoresis for proteins.
  • 15. Microbiological assay of antibiotics.

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Recommended Textbooks & References

  1. 1. Baltz, R. H., Davies, J. E. and Demain, A. L. Manual of Industrial Microbiology and Biotechnology. ASM Press.
  2. Carter, S. J. Cooper and Gunn’s Tutorial Pharmacy. CBS Publishers & Distributors.
  3. Chou, S. L. M. Practical Biotechnology: A Guide to Biochemical Engineering. Springer.
  4. Denyer, S. P., Hodges, N. A. and Gorman, S. P. Hugo and Russell’s Pharmaceutical Microbiology. Wiley-Blackwell.
  5. Glick, B. R., Pasternak, J. J. and Patten, C. L. Molecular Biotechnology: Principles and Applications of Recombinant DNA. ASM Press.
  6. Lachman, L., Lieberman, H. A., Kanig, J. L. and Khar, R. K. The Theory and Practice of Industrial Pharmacy. CBS Publishers & Distributors.
  7. Pelczar, M. J., Chan, E. C. S. and Krieg, N. R. Microbiology. McGraw-Hill.

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  • Previous year question papers (PYQ)
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