Introduction to Pharmaceutical Biotechnology MCQs With Answer
This concise set of Pharmaceutical Biotechnology MCQs with answers is designed for B.Pharm students to reinforce core concepts in biologics, recombinant DNA technology, monoclonal antibodies, bioprocessing, downstream processing, cell culture, vaccines, and analytical techniques. Questions emphasize practical applications such as GMP, aseptic technique, quality control assays (ELISA, PCR, SDS-PAGE), formulation stability, and regulatory considerations. Each question targets understanding of biopharmaceutical development, production, characterization, and safety to prepare students for exams and industry roles. Clear explanations and focused practice will build competence in modern pharmaceutical biotechnology. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary purpose of a selectable marker in a cloning vector?
- To enhance protein expression levels
- To allow identification of cells that have taken up the vector
- To increase plasmid replication speed
- To serve as a promoter for the gene of interest
Correct Answer: To allow identification of cells that have taken up the vector
Q2. Which enzyme is used to create complementary DNA (cDNA) from mRNA for cloning eukaryotic genes?
- DNA polymerase I
- Reverse transcriptase
- RNA polymerase II
- Restriction endonuclease
Correct Answer: Reverse transcriptase
Q3. In upstream bioprocessing, what is the main objective during the cell culture phase?
- Purify the target protein
- Maximize cell growth and product yield
- Formulate the drug product
- Perform endotoxin testing
Correct Answer: Maximize cell growth and product yield
Q4. Which chromatography technique separates proteins primarily based on size?
- Ion-exchange chromatography
- Affinity chromatography
- Size-exclusion chromatography
- Hydrophobic interaction chromatography
Correct Answer: Size-exclusion chromatography
Q5. What is the role of a seed train in bioreactor operation?
- To sterilize media before inoculation
- To scale up culture volume progressively to inoculate production reactors
- To purify product from harvested culture
- To measure metabolite concentrations
Correct Answer: To scale up culture volume progressively to inoculate production reactors
Q6. Which assay is commonly used for quantitative detection of specific proteins using antibody binding?
- Polymerase chain reaction (PCR)
- Enzyme-linked immunosorbent assay (ELISA)
- Western blot DNA staining
- Gas chromatography
Correct Answer: Enzyme-linked immunosorbent assay (ELISA)
Q7. What is the main advantage of using mammalian cell lines to produce therapeutic glycoproteins?
- Lower production cost than microbial systems
- Capability for human-like post-translational modifications
- Faster growth rate than bacteria
- No need for aseptic processing
Correct Answer: Capability for human-like post-translational modifications
Q8. Which regulatory guideline primarily governs good manufacturing practices for pharmaceuticals?
- ICH GMP guidelines
- EPA biosafety regulations
- ISO 9001 only
- CLSI clinical lab standards
Correct Answer: ICH GMP guidelines
Q9. What is the purpose of a bioburden test during aseptic production?
- To quantify endotoxin levels in finished product
- To determine the viable microbial load on equipment or product
- To measure protein concentration
- To assess DNA purity
Correct Answer: To determine the viable microbial load on equipment or product
Q10. Which technique is most appropriate for detecting specific DNA sequences in a sample?
- SDS-PAGE
- PCR (Polymerase Chain Reaction)
- HPLC
- ELISA
Correct Answer: PCR (Polymerase Chain Reaction)
Q11. In monoclonal antibody production, what is the hybridoma?
- A bacterial host engineered to secrete antibodies
- A fusion of antibody-producing B cell and myeloma cell to enable continuous antibody production
- A virus used as vector for antibody genes
- A chromatographic resin used for antibody purification
Correct Answer: A fusion of antibody-producing B cell and myeloma cell to enable continuous antibody production
Q12. What is an adjuvant in vaccine formulations?
- A preservative to prevent contamination
- A substance that enhances the immune response to an antigen
- A surfactant to stabilize emulsion
- A buffer to maintain pH
Correct Answer: A substance that enhances the immune response to an antigen
Q13. Which downstream step is primarily used to remove host cell proteins after fermentation?
- Ultrafiltration/diafiltration
- Affinity or ion-exchange chromatography
- Fermentation optimization
- Media sterilization
Correct Answer: Affinity or ion-exchange chromatography
Q14. What does SDS-PAGE separate proteins based on?
- Isoelectric point
- Hydrophobicity
- Molecular weight
- Affinity for antibodies
Correct Answer: Molecular weight
Q15. Which lipid-based formulation technique improves delivery of nucleic acid therapeutics into cells?
- Lyophilization
- Lipid nanoparticle encapsulation
- Ion-exchange chromatography
- Size-exclusion filtration
Correct Answer: Lipid nanoparticle encapsulation
Q16. What is the main cause of immunogenicity for therapeutic proteins?
- Excessive purity of the product
- Structural differences such as non-human sequences or glycosylation patterns
- Use of mammalian expression systems only
- High protein solubility
Correct Answer: Structural differences such as non-human sequences or glycosylation patterns
Q17. Which parameter is critical to control in a fed-batch bioreactor to prevent nutrient limitation or overflow metabolism?
- pH only
- Feed rate and composition
- Filter pore size
- Electrode calibration
Correct Answer: Feed rate and composition
Q18. What is the role of protease inhibitors during cell lysis in protein purification?
- To enhance protease activity
- To prevent degradation of target proteins by cellular proteases
- To increase cell rupture efficiency
- To change protein isoelectric point
Correct Answer: To prevent degradation of target proteins by cellular proteases
Q19. Which statement best describes recombinant DNA technology?
- Using high temperatures to denature proteins
- Manipulating DNA sequences to express desired genes in host organisms
- Measuring drug concentration in plasma
- Isolating natural products without modification
Correct Answer: Manipulating DNA sequences to express desired genes in host organisms
Q20. Which quality attribute assesses the three-dimensional structure of a biotherapeutic protein?
- Primary sequence analysis only
- Higher-order structure assessment (e.g., CD, NMR)
- Endotoxin measurement
- Osmolality
Correct Answer: Higher-order structure assessment (e.g., CD, NMR)
Q21. What is lyophilization used for in biologics manufacturing?
- To concentrate media before fermentation
- To freeze-dry products to improve stability and shelf life
- To sterilize equipment
- To denature unwanted proteins
Correct Answer: To freeze-dry products to improve stability and shelf life
Q22. Which vector is commonly used for high-level expression of proteins in E. coli?
- Adenoviral vector
- pET plasmid with T7 promoter
- pcDNA3 eukaryotic vector
- Lentiviral vector
Correct Answer: pET plasmid with T7 promoter
Q23. What is the purpose of buffer exchange (diafiltration) in downstream processing?
- To lyse cells more effectively
- To change the product environment and remove small impurities or adjust formulation
- To sequence the protein
- To analyze endotoxin content
Correct Answer: To change the product environment and remove small impurities or adjust formulation
Q24. Which safety level (BSL) is required for routine work with non-pathogenic E. coli strains used in cloning?
- BSL-4
- BSL-1
- BSL-3
- BSL-2
Correct Answer: BSL-1
Q25. In pharmacogenomics, what is a biomarker used for?
- To determine the pH of a formulation
- To predict patient response or risk for adverse reactions to biologics
- To purify monoclonal antibodies
- To sterilize drug products
Correct Answer: To predict patient response or risk for adverse reactions to biologics
Q26. Which sterilization method is most appropriate for heat-sensitive biologic formulations?
- Autoclaving at 121°C
- Filtration through 0.22 µm sterile filter
- Dry heat sterilization
- Gamma irradiation for small molecules only
Correct Answer: Filtration through 0.22 µm sterile filter
Q27. What is the main function of an expression promoter in a recombinant construct?
- To terminate transcription
- To initiate and regulate transcription of the gene of interest
- To replicate plasmid DNA
- To code for antibiotic resistance
Correct Answer: To initiate and regulate transcription of the gene of interest
Q28. During vaccine development, what does an inactivated vaccine contain?
- Live attenuated organism
- Killed or inactivated pathogen that cannot replicate
- Only purified host cell proteins
- Only plasmid DNA without antigenic protein
Correct Answer: Killed or inactivated pathogen that cannot replicate
Q29. Which analytical method provides information about glycan structures attached to therapeutic proteins?
- Mass spectrometry
- Light microscopy
- pH titration
- Simple UV absorbance at 280 nm
Correct Answer: Mass spectrometry
Q30. What is a critical consideration when scaling up a biologics process from lab to industrial scale?
- Assume cell behavior is identical at all scales
- Maintain comparable mixing, oxygen transfer, and shear conditions while ensuring product quality and reproducibility
- Only increase vessel size without changing process parameters
- Remove quality testing to speed up production
Correct Answer: Maintain comparable mixing, oxygen transfer, and shear conditions while ensuring product quality and reproducibility
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.
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