BP605T. PHARMACEUTICAL BIOTECHNOLOGY (Theory)

Unit-I

Introduction to Biotechnology:

• Definition, scope, and applications in pharmaceutical sciences.
• Enzyme Biotechnology:
• Methods of enzyme immobilization (adsorption, covalent bonding, entrapment, encapsulation).
• Applications of immobilized enzymes in drug delivery and diagnostics.
• Biosensors:
• Working principles and applications in pharmaceutical industries.
• Protein Engineering:
• Basic concepts and techniques (site-directed mutagenesis, directed evolution).
• Microbial Biotechnology:
• Role of microbes in industrial production of enzymes (amylase, catalase, peroxidase, lipase, protease, penicillinase).

Unit-II

Genetic Engineering:

• Basic Principles:
• Tools of genetic engineering: Restriction endonucleases, DNA ligase, cloning vectors (plasmids, cosmids, phages).
• Recombinant DNA technology: Steps and applications.
• Applications in Medicine:
• Production of therapeutic proteins:
  • Interferons.
  • Vaccines (e.g., Hepatitis B vaccine).
  • Hormones (e.g., Insulin).
• Polymerase Chain Reaction (PCR):
• Principles, steps, and applications in diagnostics and research.

Unit-III

Immunology and Immunotechnology:

• Types of Immunity:
• Innate and adaptive immunity.
• Humoral and cell-mediated immunity.
• Immunoglobulins:
• Structure and function of antibodies (IgG, IgM, IgA, IgE, IgD).
• Major Histocompatibility Complex (MHC):
• Structure and role in immune response.
• Hypersensitivity Reactions:
• Types (I, II, III, IV) and mechanisms.
• Vaccines and Immunotherapy:
• Preparation of bacterial vaccines, viral vaccines, toxoids, and antitoxins.
• Storage and stability of vaccines.
• Hybridoma Technology:
• Production of monoclonal antibodies (mAbs).
• Applications in diagnostics and therapeutics.

Unit-IV

Molecular Biology Techniques:

• Immuno-blotting Techniques:
• ELISA, Western blotting, Southern blotting.
• Microbial Genetics:
• Transformation, transduction, conjugation, plasmids, and transposons.
• Biotransformation:
• Microbial biotransformation and its applications in drug synthesis.
• Mutation:
• Types of mutations (point, frameshift, silent, missense, nonsense).
• Applications in strain improvement.

Unit-V

Fermentation Technology:

• Principles of Fermentation:
• Media preparation, sterilization methods, aeration, and agitation.
• Types of fermenters and their design.
• Large-Scale Production:
• Production of antibiotics (e.g., Penicillin).
• Production of organic acids (e.g., Citric acid).
• Production of vitamins (e.g., Vitamin B12).
• Production of amino acids (e.g., Glutamic acid).
• Blood Products:
• Collection, processing, and storage of whole blood, plasma, and plasma substitutes.