Introduction: Preparation of viral vaccines, antitoxins and serum derivatives is a core B.Pharm topic that covers vaccine design, antigen preparation, inactivation and attenuation methods, cell-culture and egg-based production, purification, adjuvants, potency and safety testing, and formulation/stability considerations. You will study antitoxin and antiserum production, fractionation (Cohn method), F(ab’)2 preparation, complement inactivation, and quality control assays like neutralization tests, ELISA and sterility testing. Emphasis on cold chain, lyophilization, GMP, and regulatory requirements links theory to industry practice. Mastering these keywords—viral vaccines, antitoxins, serum derivatives, inactivation, attenuation, adjuvants, fractionation—prepares you for pharmaceutical formulation and QC roles. ‘Now let’s test your knowledge with 30 MCQs on this topic.’
Q1. What is the primary purpose of inactivating a virus during vaccine production?
- To increase the virus’ replication rate
- To eliminate pathogenicity while preserving antigenicity
- To make the virus more thermostable
- To change the viral genome sequence
Correct Answer: To eliminate pathogenicity while preserving antigenicity
Q2. Which chemical is commonly used for viral inactivation by alkylation of nucleic acids during vaccine manufacture?
- Formalin (formaldehyde)
- Beta-propiolactone (BPL)
- Ethanol
- Hydrogen peroxide
Correct Answer: Beta-propiolactone (BPL)
Q3. Live attenuated vaccines are produced chiefly by which method?
- Chemical inactivation with formalin
- Serial passage in non-native hosts or culture to reduce virulence
- Pepsin digestion of IgG
- Adsorption to alum
Correct Answer: Serial passage in non-native hosts or culture to reduce virulence
Q4. Which cell substrate is commonly used for large-scale viral vaccine production due to its capacity for many viruses?
- Mouse ascites fluid
- Vero cells
- Escherichia coli
- Yeast (Saccharomyces cerevisiae)
Correct Answer: Vero cells
Q5. What is the role of an adjuvant in vaccine formulation?
- To directly kill pathogens in the vaccine
- To enhance and direct the immune response to the antigen
- To serve as an antibiotic preservative
- To neutralize endotoxin
Correct Answer: To enhance and direct the immune response to the antigen
Q6. Which assay is most suitable for measuring functional neutralizing antibodies after vaccination?
- Western blot
- Neutralization assay (virus neutralization test)
- SDS-PAGE
- Gram staining
Correct Answer: Neutralization assay (virus neutralization test)
Q7. In antitoxin production, what is a toxoid?
- An inactivated toxin that retains antigenicity but not toxicity
- A live toxic bacterium
- A monoclonal antibody against toxin
- A preservative used in vaccines
Correct Answer: An inactivated toxin that retains antigenicity but not toxicity
Q8. What is the main objective of serum fractionation (Cohn method) in producing serum derivatives?
- To denature proteins for easier storage
- To separate plasma proteins (e.g., albumin, immunoglobulins) by precipitation with ethanol
- To sterilize serum by heating to 100°C
- To convert IgG into IgM
Correct Answer: To separate plasma proteins (e.g., albumin, immunoglobulins) by precipitation with ethanol
Q9. Which processing step produces F(ab’)2 fragments from whole IgG for antivenom production?
- Pepsin digestion of IgG
- Trypsin digestion of albumin
- Heat inactivation at 56°C
- Ammonium sulfate fractionation only
Correct Answer: Pepsin digestion of IgG
Q10. Complement inactivation of serum is typically done at which condition to prevent complement-mediated effects?
- 56°C for 30 minutes
- 4°C overnight
- 100°C for 10 minutes
- Room temperature for 2 hours
Correct Answer: 56°C for 30 minutes
Q11. What is lyophilization used for in vaccine formulation?
- To increase antigen immunogenicity
- To remove moisture and stabilize vaccines for storage
- To sterilize the vaccine by UV
- To adjuvant the vaccine with aluminum salts
Correct Answer: To remove moisture and stabilize vaccines for storage
Q12. Which preservative has been historically used in some vaccines to prevent bacterial contamination?
- Thimerosal
- Sodium chloride
- Glucose
- Magnesium sulfate
Correct Answer: Thimerosal
Q13. Which method is commonly used to assess protein purity and molecular weight of vaccine antigens or serum proteins?
- ELISA
- SDS-PAGE
- Gram staining
- Hemagglutination assay
Correct Answer: SDS-PAGE
Q14. What is the principle behind the Limulus Amebocyte Lysate (LAL) test in vaccine safety?
- Detection of viral nucleic acids
- Detection of bacterial endotoxin (LPS)
- Measurement of antibody titers
- Determination of protein concentration
Correct Answer: Detection of bacterial endotoxin (LPS)
Q15. Which regulatory concept ensures traceability and consistent quality of viral vaccine seed stocks?
- Cold chain maintenance
- Seed lot system (master and working seed lots)
- Lyophilization
- Adjuvant selection
Correct Answer: Seed lot system (master and working seed lots)
Q16. What is the main risk associated with live attenuated vaccines?
- Reversion to virulence and risk in immunocompromised hosts
- Immediate anaphylaxis in all recipients
- Complete inability to induce immune response
- High levels of endotoxin contamination
Correct Answer: Reversion to virulence and risk in immunocompromised hosts
Q17. In antivenom production, hyperimmune serum is obtained by:
- Vaccinating animals repeatedly with venom to raise high antibody titers
- Heat-treating normal serum to increase antibodies
- Pooling human sera without immunization
- Using recombinant monoclonal antibodies only
Correct Answer: Vaccinating animals repeatedly with venom to raise high antibody titers
Q18. Which chromatographic technique is widely used for vaccine antigen purification based on size?
- Ion-exchange chromatography
- Size-exclusion chromatography (gel filtration)
- Affinity chromatography using protein A only
- Thin-layer chromatography
Correct Answer: Size-exclusion chromatography (gel filtration)
Q19. What is the role of potency testing in vaccine quality control?
- To confirm sterility only
- To quantify biological activity and ensure effective immune response
- To determine color and odor of vaccine
- To measure endotoxin exclusively
Correct Answer: To quantify biological activity and ensure effective immune response
Q20. Which of the following is a common method to remove host cell proteins and DNA from viral vaccine harvest?
- Dialysis only
- Chromatography and nuclease treatment combined with ultrafiltration
- Direct heating to 80°C
- Adding adjuvant to precipitate impurities
Correct Answer: Chromatography and nuclease treatment combined with ultrafiltration
Q21. In serum derivative production, ammonium sulfate precipitation is used primarily to:
- Sterilize the serum
- Selectively precipitate and concentrate immunoglobulins
- Denature proteins irreversibly
- Remove endotoxin
Correct Answer: Selectively precipitate and concentrate immunoglobulins
Q22. Which immunoglobulin class is most abundant in therapeutic human immunoglobulin preparations used for passive immunization?
- IgM
- IgG
- IgA
- IgE
Correct Answer: IgG
Q23. What is a commonly used in-process test to detect viral antigen presence during vaccine purification?
- Gram staining
- ELISA
- pH indicator strip
- Coagulation time test
Correct Answer: ELISA
Q24. Which parameter is critical for maintaining vaccine potency during distribution?
- Constant exposure to sunlight
- Cold chain temperature control
- Frequent agitation
- Storage at room temperature for months
Correct Answer: Cold chain temperature control
Q25. Which step helps reduce the risk of serum-derived infectious agents in antitoxin preparations?
- Use of non-sterile equipment
- Pasteurization, solvent/detergent treatment and viral filtration
- Increasing antibody concentration only
- Storing at room temperature
Correct Answer: Pasteurization, solvent/detergent treatment and viral filtration
Q26. How does formalin inactivate toxins and viruses in vaccine production?
- By chelating metal ions
- By cross-linking proteins and nucleic acids to abolish biological activity
- By dehydrating the antigen
- By enzymatic digestion
Correct Answer: By cross-linking proteins and nucleic acids to abolish biological activity
Q27. What is the reason for using alum (aluminum salts) in many vaccines?
- To serve as a stabilizer by preventing freezing
- To act as an adjuvant that promotes Th2-biased antibody responses
- To inactivate live virus
- To digest antigens into peptides
Correct Answer: To act as an adjuvant that promotes Th2-biased antibody responses
Q28. Which test would be used to confirm sterility of a vaccine batch?
- Sterility test by incubation in culture media for bacteria and fungi
- Neutralization assay
- Protein content by Lowry method only
- Hemagglutination inhibition
Correct Answer: Sterility test by incubation in culture media for bacteria and fungi
Q29. Which statement best describes passive immunization with antiserum?
- It induces long-lasting memory B-cell responses
- It provides immediate but temporary protection via transferred antibodies
- It relies on attenuated live microbes to stimulate immunity
- It is equivalent to active vaccination with toxoids
Correct Answer: It provides immediate but temporary protection via transferred antibodies
Q30. What is the advantage of producing recombinant subunit viral vaccines over whole-virus vaccines?
- Higher risk of reversion to virulence
- Lower safety risk and focused antigenicity with easier standardization
- They always generate stronger cellular immunity than live vaccines
- They do not require any purification steps
Correct Answer: Lower safety risk and focused antigenicity with easier standardization
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
Mail- Sachin@pharmacyfreak.com