Pharmaceutical Biotechnology and Novel Drug Delivery
Pharmaceutical Biotechnology and Novel Drug Delivery tests recombinant products, biopharmaceutical characterisation and advanced delivery systems - an expanding area in Indian regulation.
Core rules
- Recombinant technology: host systems (E. coli, yeast, CHO cells), plasmids, restriction enzymes, PCR, Southern and Western blotting, ELISA.
- Products: human insulin, erythropoietin, interferons, monoclonal antibodies, factor VIII, vaccines and gene therapies.
- Biosimilars: not generic copies; they require comparability of quality, safety and efficacy against the reference product, with immunogenicity assessment. ICH Q5 covers the quality of biotechnological products, and comparability after a process change is mandatory.
- Delivery systems: liposomes, niosomes, nanoparticles, microspheres, transdermal patches, osmotic pumps, implants and ligand-conjugated targeted systems.
- Stability: cold chain, aggregation, deamidation and oxidation; sterilise by filtration, not heat.
Worked example
A liposomal batch is prepared with 100 mg lipid and 10 mg drug. After separation, 2.5 mg drug is found free in the supernatant. Entrapment efficiency = (10 − 2.5)/10 × 100 = 75%, and the drug-to-lipid ratio is 10:100 = 1:10 w/w. Both figures must be reported, because a good ratio with poor efficiency still wastes drug.
Traps
Do not call a biosimilar a generic; do not heat-sterilise proteins; do not confuse entrapment efficiency with drug loading; and remember that liposome stability depends on vesicle size, charge and cholesterol content.