MPharm Master of Pharmacy Pharmaceutical Microbiology and Biotechnology 2

Question 1

Which expression system is most commonly used for the production of recombinant therapeutic proteins requiring complex post-translational modifications like glycosylation?

Accepted Answer

Chinese Hamster Ovary (CHO) cell culture

Answer

CHO cells produce human-like glycosylation patterns essential for the safety, efficacy, and pharmacokinetics of therapeutic glycoproteins like monoclonal antibodies.

Question 2

What is the purpose of a 2-micron (2 µm) filter used in a downstream biopharmaceutical purification process?

Accepted Answer

Removal of whole cells and cell debris

Answer

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.

Question 3

Which chromatography technique is the primary purification step for monoclonal antibody (mAb) manufacturing?

Accepted Answer

Protein A affinity chromatography

Answer

Protein A affinity chromatography selectively captures IgG antibodies via the Fc region with high specificity and yield, achieving >95% purity in a single step.

Question 4

In pharmaceutical biotechnology, what is the role of biosimilars?

Accepted Answer

Biological products highly similar to an already-approved reference biologic with no clinically meaningful differences

Answer

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.

Question 5

What is the purpose of the Mycoplasma testing requirement for cell-culture-derived biopharmaceuticals per FDA guidelines?

Accepted Answer

Mycoplasma are wall-less bacteria that can contaminate bioreactors and would pass standard bacterial sterility filters, making detection mandatory

Answer

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.

MPharm Master of Pharmacy Practice Test

MPharm Master of Pharmacy Practice Test

MPharm Master of Pharmacy Pharmaceutical Microbiology and Biotechnology 2