Pharmaceutical Microbiology and Biotechnology Flashcards
6 cards from real MPharm Master of Pharmacy practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 Pharmaceutical Microbiology and Biotechnology flashcards as text
Which expression system is most commonly used for the production of recombinant therapeutic proteins requiring complex post-translational modifications like glycosylation?
Answer: Chinese Hamster Ovary (CHO) cell culture
CHO cells produce human-like glycosylation patterns essential for the safety, efficacy, and pharmacokinetics of therapeutic glycoproteins like monoclonal antibodies.
What is the purpose of a 2-micron (2 µm) filter used in a downstream biopharmaceutical purification process?
Answer: Removal of whole cells and cell debris
Coarser depth and membrane filters in the 1–5 µm range are used in initial bioprocessing steps to remove whole cells and large debris before chromatography.
Which chromatography technique is the primary purification step for monoclonal antibody (mAb) manufacturing?
Answer: Protein A affinity chromatography
Protein A affinity chromatography selectively captures IgG antibodies via the Fc region with high specificity and yield, achieving >95% purity in a single step.
In pharmaceutical biotechnology, what is the role of biosimilars?
Answer: Biological products highly similar to an already-approved reference biologic with no clinically meaningful differences
Biosimilars are biological products approved via an abbreviated pathway demonstrating they are highly similar to a reference product with no clinically meaningful differences in safety, purity, and potency.
What is the purpose of the Mycoplasma testing requirement for cell-culture-derived biopharmaceuticals per FDA guidelines?
Answer: Mycoplasma are wall-less bacteria that can contaminate bioreactors and would pass standard bacterial sterility filters, making detection mandatory
Mycoplasmas lack cell walls and pass through 0.22 µm sterilizing filters, making them a significant contamination risk in mammalian cell culture requiring dedicated testing.
Which analytical technique is used to confirm the primary sequence and post-translational modifications of a recombinant therapeutic protein?
Answer: Peptide mapping with LC-MS/MS
Peptide mapping combined with LC-MS/MS digests the protein into fragments and identifies their sequences and modifications, confirming protein identity and structural integrity.