Production of blood products MCQs With Answer

This quiz collection on the production of blood products is tailored for M.Pharm students studying Advanced Pharmaceutical Biotechnology. It focuses on practical and regulatory aspects of preparing plasma-derived and cellular blood components, including fractionation methods, viral inactivation/removal, purification technologies, stabilization and formulation, quality control assays, and storage/handling. Questions probe deeper mechanisms—why specific steps are used, how process choices affect safety and efficacy, and which analytical tests ensure compliance with pharmacopeial standards. Use these MCQs to test your understanding of manufacturing workflows, pathogen-reduction strategies, and critical control points that ensure that blood-derived therapeutics are both safe and effective for clinical use.

Q1. Which fundamental principle underlies the classical Cohn fractionation method used for plasma protein separation?

• Chromatographic separation using resins with specific ligand binding
• Selective enzymatic digestion of unwanted proteins
• Differential ethanol precipitation at controlled temperature, pH and ionic strength
• High-speed centrifugation at room temperature to separate proteins by density

Correct Answer: Differential ethanol precipitation at controlled temperature, pH and ionic strength

Q2. Cryoprecipitate, produced from thawed frozen plasma, is primarily used clinically because it is enriched in which components?

• Albumin and immunoglobulin G
• Platelets and leukocytes
• Concentrated fibrinogen, factor VIII and von Willebrand factor
• Complement proteins C3 and C4

Correct Answer: Concentrated fibrinogen, factor VIII and von Willebrand factor

Q3. Solvent/detergent (S/D) treatment for plasma-derived products is effective primarily against which type of pathogen?

• Non-enveloped viruses such as hepatitis A and parvovirus B19
• Enveloped viruses such as HIV, HBV and HCV
• Bacterial endotoxins
• Prions (transmissible spongiform encephalopathies)

Correct Answer: Enveloped viruses such as HIV, HBV and HCV

Q4. What is the typical first large-scale processing step in manufacturing intravenous immunoglobulin (IVIG) from pooled plasma?

• Affinity chromatography on Protein A to capture IgG
• Ultrafiltration to remove albumin
• Bulk fractionation of pooled plasma (e.g., ethanol precipitation) followed by chromatographic polishing
• Lyophilization of whole plasma

Correct Answer: Bulk fractionation of pooled plasma (e.g., ethanol precipitation) followed by chromatographic polishing

Q5. Which downstream process is commonly used to remove IgA and IgM impurities and non-IgG proteins during IVIG manufacture?

• Caprylic acid precipitation to selectively precipitate non-IgG proteins
• Heat pasteurization at 60°C for 10 hours
• Gel electrophoresis separation
• Protein A/G affinity chromatography to bind IgG

Correct Answer: Caprylic acid precipitation to selectively precipitate non-IgG proteins

Q6. Which viral clearance/removal step uses size-exclusion to physically retain viruses above a specified pore size?

• Solvent/detergent treatment
• Nanofiltration (virus filtration)
• Pasteurization in solution
• Gamma irradiation

Correct Answer: Nanofiltration (virus filtration)

Q7. Which analytical method is routinely used to assess purity and detect degradation products of albumin preparations produced from plasma?

• Thin-layer chromatography (TLC)
• SDS-PAGE and densitometric analysis
• Direct spectrophotometry at 220 nm only
• Hemagglutination assay

Correct Answer: SDS-PAGE and densitometric analysis

Q8. What is the recommended storage condition for Fresh Frozen Plasma (FFP) intended for transfusion to preserve coagulation factor activity?

• Refrigerated at 2–6°C for up to 35 days
• Frozen at ≤ −18°C (often −30°C) until thawing
• Room temperature with gentle agitation
• Lyophilized and stored at ambient temperature

Correct Answer: Frozen at ≤ −18°C (often −30°C) until thawing

Q9. A primary advantage of recombinant clotting factor concentrates over plasma‑derived concentrates is:

• Lower unit cost and simpler cold chain requirements
• Higher antigenic variability between lots
• Elimination of risk for plasma‑derived blood‑borne pathogen transmission
• Ability to supply multiple clotting factors in a single product

Correct Answer: Elimination of risk for plasma‑derived blood‑borne pathogen transmission

Q10. Which pathogen-reduction technology is based on a psoralen compound activated by UVA light to cross-link nucleic acids in platelets?

• Solvent/detergent treatment
• Amotosalen (psoralen) combined with UVA illumination (Intercept)
• Heat pasteurization
• Nanofiltration

Correct Answer: Amotosalen (psoralen) combined with UVA illumination (Intercept)

Q11. Pepsin digestion during immunoglobulin processing is used to produce which product and what is the main rationale?

• Intact IgG to increase Fc-mediated effector functions
• F(ab’)2 fragments by cleaving Fc to reduce complement activation and Fc-dependent reactions
• IgM-enriched fraction to enhance agglutination
• Albumin fragments to improve osmotic activity

Correct Answer: F(ab’)2 fragments by cleaving Fc to reduce complement activation and Fc-dependent reactions

Q12. Plasma-derived factor VIII concentrates are commonly obtained by which process sequence?

• Plateletpheresis followed by leukoreduction
• Isolation of cryoprecipitate from pooled plasma, chromatographic purification and viral inactivation
• Direct recombinant expression in mammalian cell culture only
• Dialysis of whole blood to concentrate factors

Correct Answer: Isolation of cryoprecipitate from pooled plasma, chromatographic purification and viral inactivation

Q13. Which assay is the standard functional test to determine the potency of a coagulation factor concentrate?

• ELISA for antigen quantification
• One‑stage clotting assay (functional clotting activity in IU)
• Mass spectrometry‑based protein quantitation
• Western blot for protein identity

Correct Answer: One‑stage clotting assay (functional clotting activity in IU)

Q14. Which excipients are commonly included in liquid human albumin formulations to stabilize the protein during storage?

• Polyethylene glycol and benzyl alcohol
• Sodium caprylate and N‑acetyltryptophanate as stabilizers
• High concentrations of ethanol
• Strong reducing agents like β‑mercaptoethanol

Correct Answer: Sodium caprylate and N‑acetyltryptophanate as stabilizers

Q15. In plasma protein manufacturing, ultrafiltration/diafiltration is primarily used for what purpose?

• Selective enzymatic cleavage of proteins
• Removal of viral particles by solvent action
• Concentration of product and buffer exchange (diafiltration)
• Producing cryoprecipitate by freezing and thawing

Correct Answer: Concentration of product and buffer exchange (diafiltration)

Q16. Which of the following tests is most sensitive for early detection of viral contamination in plasma donors?

• Serologic antibody testing only
• Nucleic acid testing (NAT) for viral genomes
• Culture in bacterial media
• Visual inspection of plasma color

Correct Answer: Nucleic acid testing (NAT) for viral genomes

Q17. Leukoreduction of blood components prior to storage and transfusion primarily aims to reduce what risk?

• Transmission of prion diseases
• Febrile non‑hemolytic transfusion reactions and CMV transmission
• Loss of coagulation factor activity
• Platelet aggregation during storage

Correct Answer: Febrile non‑hemolytic transfusion reactions and CMV transmission

Q18. A major bioprocess challenge when manufacturing high‑concentration IVIG formulations is:

• Ensuring sterility without any downstream viral inactivation
• Preventing IgG aggregation and maintaining monomeric functionality while preserving viral safety
• Removing all albumin to undetectable levels
• Producing IgM-rich preparations exclusively

Correct Answer: Preventing IgG aggregation and maintaining monomeric functionality while preserving viral safety

Q19. Which analytical technique is standard for quantifying residual organic solvents used in some plasma-processing steps?

• Gas chromatography (GC) with appropriate detectors
• UV-visible spectrophotometry at 280 nm
• Capillary electrophoresis for large proteins
• Direct microscopy

Correct Answer: Gas chromatography (GC) with appropriate detectors

Q20. Why do regulatory frameworks often impose limits on pooled plasma batch size for fractionation?

• To increase manufacturing complexity and cost
• To reduce the risk that a single contaminated donation compromises the entire pool and to maintain traceability
• To prevent formation of cryoprecipitate
• To ensure each pool contains only one blood group

Correct Answer: To reduce the risk that a single contaminated donation compromises the entire pool and to maintain traceability

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