Production of vaccines MCQs With Answer

Production of vaccines MCQs With Answer

This blog presents a focused set of multiple-choice questions on vaccine production tailored for M.Pharm students preparing for advanced pharmaceutical biotechnology examinations. It covers upstream and downstream processes, vaccine platforms (live attenuated, inactivated, subunit, conjugate, viral-vectored, mRNA), quality control assays, adjuvants, stabilization, and regulatory considerations. Each question is designed to test conceptual understanding and practical manufacturing knowledge: cell substrates and banks, MOI and bioreactor parameters, inactivation chemistries, purification strategies, potency assays, sterility and safety limits, and cold-chain requirements. Use these MCQs to deepen technical insight, identify knowledge gaps, and reinforce principles essential for vaccine development and GMP production.

Q1. Which cell substrate is most commonly used for high-yield production of influenza virus vaccine using traditional methods?

• Vero cell line
• Primary chicken embryo fibroblasts
• Embryonated chicken eggs
• HEK293 suspension culture

Correct Answer: Embryonated chicken eggs

Q2. Inactivation of viral vaccines by formaldehyde primarily acts by which mechanism?

• Alkylation of nucleic acids leading to fragmentation
• Cross-linking proteins and nucleic acids to preserve structure but abolish infectivity
• Oxidative cleavage of lipid envelopes
• Selective depurination of viral RNA

Correct Answer: Cross-linking proteins and nucleic acids to preserve structure but abolish infectivity

Q3. Which of the following downstream techniques is most suitable for concentrating and diafiltering viral vaccine harvests while preserving viral particle integrity?

• Size-exclusion chromatography
• Tangential flow filtration (TFF)
• Affinity chromatography with Protein A
• Precipitation with ammonium sulfate

Correct Answer: Tangential flow filtration (TFF)

Q4. For recombinant protein subunit vaccines produced in E. coli, which critical quality attribute is most concerned with host cell impurity?

• Residual endotoxin levels
• Particle size distribution
• Glycosylation pattern
• Viral clearance capacity

Correct Answer: Residual endotoxin levels

Q5. The Single Radial Immunodiffusion (SRID) assay is primarily used in influenza vaccine production to measure which parameter?

• Hemagglutinin-specific antibody titers in serum
• Hemagglutinin antigen content (HA potency)
• Neuraminidase enzymatic activity
• Viral infectivity (TCID50)

Correct Answer: Hemagglutinin antigen content (HA potency)

Q6. Which adjuvant is an aluminum-based compound commonly used to enhance humoral responses in many licensed vaccines?

• MF59
• AS04
• Alum (aluminum hydroxide or aluminum phosphate)
• Monophosphoryl lipid A (MPL)

Correct Answer: Alum (aluminum hydroxide or aluminum phosphate)

Q7. In viral vector vaccine manufacturing, multiplicity of infection (MOI) is defined as:

• The ratio of infectious particles to total protein mass
• The number of infectious viral particles per target cell at infection
• The fraction of defective particles in a lot
• The ratio of genome copies to plaque-forming units

Correct Answer: The number of infectious viral particles per target cell at infection

Q8. Which method is most appropriate to confirm absence of replication-competent retrovirus in a viral vector vaccine lot?

• Endotoxin testing using LAL assay
• In vitro indicator cell line assay for replication-competent viruses
• SRID potency assay
• Protein aggregation analysis by SEC

Correct Answer: In vitro indicator cell line assay for replication-competent viruses

Q9. For conjugate vaccines, a carrier protein such as CRM197 is used to:

• Improve thermostability of the polysaccharide antigen
• Enhance T-cell dependent immune response to the polysaccharide
• Act as a preservative to prevent contamination
• Serve as an adjuvant to recruit innate immunity

Correct Answer: Enhance T-cell dependent immune response to the polysaccharide

Q10. Which inactivation agent is preferred when rapid inactivation of enveloped viruses is required while maintaining antigenic sites, commonly used for rabies vaccines?

• β-propiolactone (BPL)
• Trichloroacetic acid
• Glutaraldehyde
• Heat treatment at 100°C

Correct Answer: β-propiolactone (BPL)

Q11. In mRNA vaccine lipid nanoparticle (LNP) formulations, which component primarily facilitates endosomal escape of mRNA into the cytosol?

• Cholesterol
• Ionizable cationic lipids
• Polyethylene glycol (PEG)-lipid
• Neutral helper lipids like DSPC

Correct Answer: Ionizable cationic lipids

Q12. Which regulatory document/guideline specifically addresses viral safety evaluation for biotechnology-derived products relevant to vaccine production?

• ICH Q5A (Viral safety evaluation of biotechnology products)
• ICH Q7 (Good manufacturing practice for APIs)
• ICH Q8 (Pharmaceutical development)
• ICH Q9 (Quality risk management)

Correct Answer: ICH Q5A (Viral safety evaluation of biotechnology products)

Q13. A master cell bank (MCB) differs from a working cell bank (WCB) in that the MCB is:

• Prepared from the first clinical batch and used directly in production without testing
• The primary frozen stock characterized extensively and used to create WCBs
• Kept at room temperature for rapid access during production
• Always derived from human donor material at point of use

Correct Answer: The primary frozen stock characterized extensively and used to create WCBs

Q14. Which assay is most appropriate for quantifying residual host cell DNA in a purified vaccine intermediate?

• qPCR specific for host cell genomic sequences
• BCA protein assay
• Hemagglutination inhibition assay
• Limulus amebocyte lysate (LAL) assay

Correct Answer: qPCR specific for host cell genomic sequences

Q15. Lyophilization (freeze drying) of vaccines commonly includes excipients like sugars (e.g., sucrose, trehalose) primarily to:

• Increase osmolarity for better adjuvant activity
• Stabilize proteins and viral particles by forming a glassy matrix during drying
• Act as preservatives to prevent microbial growth
• Enhance antigen uptake at the injection site

Correct Answer: Stabilize proteins and viral particles by forming a glassy matrix during drying

Q16. Which purification technique is most suitable for removing host cell proteins while retaining a specific recombinant protein antigen with a His-tag?

• Ion-exchange chromatography
• Hydrophobic interaction chromatography
• Immobilized metal affinity chromatography (IMAC)
• Ultracentrifugation through sucrose cushion

Correct Answer: Immobilized metal affinity chromatography (IMAC)

Q17. The potency of an inactivated whole-virus vaccine is often assessed by:

• Measurement of residual live virus by plaque assay only
• Assays that quantify antigen-specific immune responses or antigen content correlated to protection
• Total protein concentration irrespective of antigen integrity
• Endotoxin level as a surrogate for immunogenicity

Correct Answer: Assays that quantify antigen-specific immune responses or antigen content correlated to protection

Q18. Cold chain requirement for most licensed live attenuated vaccines is typically maintained at which temperature range to preserve potency?

• −80°C to −60°C
• 2°C to 8°C
• 15°C to 25°C
• Room temperature with desiccant

Correct Answer: 2°C to 8°C

Q19. Which of the following is a critical test to detect bacterial endotoxin contamination in parenteral vaccine lots?

• Mycoplasma PCR assay
• Limulus amebocyte lysate (LAL) assay
• Freund’s adjuvant challenge test
• SRID potency assay

Correct Answer: Limulus amebocyte lysate (LAL) assay

Q20. For recombinant viral-vectored vaccines, which strategy is commonly used during purification to separate empty capsids from genome-containing capsids?

• Size-exclusion chromatography with a desalting step
• Density gradient ultracentrifugation (e.g., CsCl or iodixanol gradients)
• Ion-exchange in flow-through mode only
• Heat shock to precipitate empty capsids

Correct Answer: Density gradient ultracentrifugation (e.g., CsCl or iodixanol gradients)

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