[MICRO-08] Pharmaceutical Biotechnology: Recombinant DNA, Therapeutic Proteins, Biosimilars & Monoclonal Antibodies

MICRO-08 • 8. Biochemistry

Learning Objectives

Trace recombinant DNA (rDNA) production of Human Insulin ([7.4] Regular, [7.5] Glargine, [7.6] Lispro), [10.11] Erythropoietin, and Recombinant [12.24] Hepatitis B Vaccine.; Apply hybridoma technology (Köhler & Milstein, HAT medium selection) and decode WHO INN nomenclature for Monoclonal Antibodies (-omab, -ximab, -zumab, -umab).; Explain CDSCO–DBT Guidelines on Similar Biologics (Biosimilars) in India.

Chapter Overview & Core Explanation

Biotechnology uses living cells (like E. coli bacteria, Saccharomyces yeast, or Chinese Hamster Ovary mammalian cells) programmed with human genes to manufacture complex biological medicines such as human insulin, erythropoietin, vaccines, and targeted monoclonal antibodies.

Key Exam & Clinical Takeaways

• [7.5] Insulin Glargine has glycine at A21 and two added arginines at B31–B32, shifting its isoelectric point to neutral pH, whereas [7.6] Insulin Lispro reverses Pro-B28 and Lys-B29 to prevent hexamer formation.
• Glycosylated therapeutic proteins like [10.11] Erythropoietin must be produced in mammalian cells (CHO cells) rather than E. coli because sialic acid glycosylation is essential for their in-vivo half-life.

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