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 mechanism confers methicillin resistance in Staphylococcus aureus (MRSA)?
Answer: Acquisition of the mecA gene encoding PBP2a with low affinity for beta-lactams
The mecA gene encodes penicillin-binding protein 2a (PBP2a), which has very low affinity for all beta-lactam antibiotics, allowing cell wall synthesis to continue despite drug presence.
In the pharmaceutical industry, what is a GMP (Good Manufacturing Practice) 'cleaning validation' designed to demonstrate?
Answer: That cleaning procedures effectively remove residues of previous products, cleaning agents, and microorganisms below acceptable limits
Cleaning validation confirms that established cleaning procedures consistently reduce product carryover, detergent residues, and microbial contamination to scientifically justified acceptable levels.
What is the critical quality attribute (CQA) most important for determining the potency of a monoclonal antibody therapeutic?
Answer: Fc receptor binding and ADCC activity
For most therapeutic mAbs, Fc-mediated effector functions such as ADCC (antibody-dependent cellular cytotoxicity) directly determine clinical potency and must be controlled during manufacturing.
Which type of vaccine platform is represented by the COVID-19 Pfizer-BioNTech vaccine?
Answer: mRNA-lipid nanoparticle vaccine
The Pfizer-BioNTech vaccine delivers mRNA encoding the SARS-CoV-2 spike protein encapsulated in lipid nanoparticles, representing a novel vaccine biotechnology platform.
In cell-based therapy manufacturing, what is the purpose of characterizing the 'critical process parameters' (CPPs) of bioreactor culture?
Answer: To identify process variables (pH, DO, temperature) that directly impact critical quality attributes of the cell therapy product
CPPs are process variables whose variation impacts product CQAs; controlling them within defined ranges ensures consistent product quality, safety, and efficacy for cell therapies.
Which regulatory pathway allows manufacturers to submit a Biologics License Application (BLA) for a biosimilar in the United States?
Answer: Section 351(k) of the Public Health Service (PHS) Act
The Biologics Price Competition and Innovation Act created Section 351(k) of the PHS Act, allowing an abbreviated approval pathway for biosimilar biologics referencing an approved reference product.