Applications of biotechnology in pharmaceutical sciences MCQs With Answer

Applications of biotechnology in pharmaceutical sciences encompass diverse tools and techniques that transform drug discovery, development, production and quality control for B.Pharm students to master. Key areas include recombinant DNA technology, monoclonal antibodies, vaccine production, gene therapy, pharmacogenomics, and biopharmaceutical manufacturing. Biotechnology enables targeted therapeutics, biologics formulation, advanced diagnostics, and scalable bioprocessing using microbial, mammalian, and plant expression systems. Understanding analytical methods, regulatory requirements, biosimilars, GMP and bioinformatics is essential for safe, effective medicines. This concise MCQ set focuses on real-world applications, laboratory principles, and regulatory considerations to deepen conceptual understanding and exam readiness. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which expression system is most commonly used for producing monoclonal antibodies at commercial scale?

• Escherichia coli expression system
• Yeast (Saccharomyces cerevisiae) expression system
• Insect cell (baculovirus) expression system
• Mammalian cell (CHO) expression system

Correct Answer: Mammalian cell (CHO) expression system

Q2. Recombinant DNA technology primarily involves which of the following steps?

• Genome sequencing only
• Cutting and joining DNA fragments using restriction enzymes and ligases
• Protein crystallization
• Oral drug formulation

Correct Answer: Cutting and joining DNA fragments using restriction enzymes and ligases

Q3. Which analytical technique is most specific for quantifying a monoclonal antibody in a biological sample?

• UV-visible spectrophotometry
• Sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE)
• Enzyme-linked immunosorbent assay (ELISA)
• Thin-layer chromatography (TLC)

Correct Answer: Enzyme-linked immunosorbent assay (ELISA)

Q4. What is the main advantage of using recombinant insulin over animal-derived insulin?

• Higher potency per dose
• Lower production cost than all methods
• Reduced immunogenicity and safer supply
• Longer shelf-life without refrigeration

Correct Answer: Reduced immunogenicity and safer supply

Q5. Which of the following best describes a biosimilar?

• An identical copy of a small-molecule drug
• A biologic highly similar to an approved reference biologic with no clinically meaningful differences
• An herbal supplement used in drug therapy
• A generic chemical synthesized by combinatorial chemistry

Correct Answer: A biologic highly similar to an approved reference biologic with no clinically meaningful differences

Q6. Which technique is used for gene editing to create knockout cell lines used in pharmaceutical research?

• Polymerase chain reaction (PCR)
• CRISPR-Cas9 system
• Western blotting
• Gas chromatography

Correct Answer: CRISPR-Cas9 system

Q7. In bioprocessing, what does upstream processing refer to?

• Purification and formulation of the final product
• Quality control testing after production
• Cell culture, fermentation and growth of expression hosts
• Packaging and distribution

Correct Answer: Cell culture, fermentation and growth of expression hosts

Q8. Which viral vector is commonly used in gene therapy for long-term expression in non-dividing cells?

• Adeno-associated virus (AAV)
• Lentivirus
• Retrovirus
• Adenovirus

Correct Answer: Adeno-associated virus (AAV)

Q9. Pharmacogenomics in biotechnology primarily helps with which objective?

• Increasing production yields in fermentation
• Predicting patient responses and tailoring drug therapy based on genetics
• Accelerating chromatographic separations
• Standardizing packaging labels

Correct Answer: Predicting patient responses and tailoring drug therapy based on genetics

Q10. Which purification method is most suitable for capturing antibodies from cell culture supernatant?

• Ion-exchange chromatography
• Protein A affinity chromatography
• Size-exclusion chromatography
• Reverse-phase HPLC

Correct Answer: Protein A affinity chromatography

Q11. Which assay is commonly used to quantify nucleic acids during molecular biology workflows?

• Bradford protein assay
• PicoGreen or Qubit fluorometric assays
• ELISA for proteins
• Phenol red colorimetric test

Correct Answer: PicoGreen or Qubit fluorometric assays

Q12. Which statement about monoclonal antibodies (mAbs) is true?

• mAbs are small synthetic molecules made by chemical synthesis
• mAbs recognize a single epitope on an antigen
• mAbs are always derived from plant expression systems
• mAbs cannot be humanized

Correct Answer: mAbs recognize a single epitope on an antigen

Q13. What is the role of adjuvants in vaccine biotechnology?

• Stabilize the vaccine during shipping only
• Suppress immune response to reduce side effects
• Enhance and direct the immune response to antigen
• Act as preservatives to extend shelf life

Correct Answer: Enhance and direct the immune response to antigen

Q14. Which quality guideline is most relevant for manufacturing biopharmaceuticals?

• ICH Q8 (Pharmaceutical Development)
• ICH Q5A/B/C (Biologicals) and GMP regulations
• USP monographs only
• ISO 9001 exclusively

Correct Answer: ICH Q5A/B/C (Biologicals) and GMP regulations

Q15. Which method is widely used for detecting specific proteins in complex samples by size and antibody recognition?

• PCR
• Western blotting
• Mass spectrometry only
• ELISPOT

Correct Answer: Western blotting

Q16. In vaccine production, which platform offers rapid design and scalability for novel antigens?

• Live attenuated bacterial cultures
• mRNA vaccine platforms
• Traditional egg-based influenza production only
• Topical creams

Correct Answer: mRNA vaccine platforms

Q17. What is the primary concern when expressing human proteins in bacterial hosts?

• Excessive glycosylation
• Incorrect folding and lack of post-translational modifications
• Too high molecular weight
• Excessive cost of culture media

Correct Answer: Incorrect folding and lack of post-translational modifications

Q18. Which regulatory concept ensures consistent production and control of biologics batch-to-batch?

• Quality by Exception
• Quality by Design (QbD)
• Ad hoc testing
• Randomized release

Correct Answer: Quality by Design (QbD)

Q19. Which of the following is a key downstream processing challenge for biopharmaceuticals?

• Designing novel promoter sequences
• Removing host cell proteins, DNA and viral contaminants
• Sequencing the expression plasmid
• Developing tablet coatings

Correct Answer: Removing host cell proteins, DNA and viral contaminants

Q20. Which biotechnology tool is essential for rapid amplification of a specific DNA fragment?

• Western blot
• Polymerase chain reaction (PCR)
• Flow cytometry
• Immunoprecipitation

Correct Answer: Polymerase chain reaction (PCR)

Q21. Which statement about biosafety in biopharmaceutical labs is correct?

• Biosafety is optional for well-trained staff only
• Containment, PPE and SOPs are essential to prevent contamination and exposure
• PCR machines eliminate need for aseptic technique
• Only viral work needs biosafety measures

Correct Answer: Containment, PPE and SOPs are essential to prevent contamination and exposure

Q22. Which platform is preferred for producing glycosylated human therapeutic proteins?

• Escherichia coli
• Yeast lacking humanized glycosylation
• Mammalian cell lines such as CHO
• Cell-free extract only

Correct Answer: Mammalian cell lines such as CHO

Q23. What does “sterile filtration” typically remove during biologic formulation?

• Small molecules and salts
• Particles and microorganisms above filter pore size (e.g., 0.22 µm)
• DNA sequences
• All protein aggregates

Correct Answer: Particles and microorganisms above filter pore size (e.g., 0.22 µm)

Q24. Which assay is commonly used to measure cell viability during bioprocess optimization?

• MTT or resazurin (alamarBlue) assay
• Gram staining
• Protein A chromatography
• Isoelectric focusing

Correct Answer: MTT or resazurin (alamarBlue) assay

Q25. Which concept describes the removal of pyrogens and endotoxins from parenteral biologic products?

• Pasteurization
• Endotoxin removal and validation (e.g., LAL testing)
• Lyophilization only
• pH adjustment only

Correct Answer: Endotoxin removal and validation (e.g., LAL testing)

Q26. Which component in a bioreactor helps maintain proper oxygen transfer for aerobic cell cultures?

• Antifoam only
• Agitation and sparging (aeration)
• Chromatography column
• Protein A resin

Correct Answer: Agitation and sparging (aeration)

Q27. Which omics technology directly informs targeted drug development by identifying protein expression changes?

• Genomics
• Proteomics
• Metabolomics exclusively
• Pharmacokinetics alone

Correct Answer: Proteomics

Q28. In context of biologics, what is “aggregate formation” and why is it important?

• Formation of small chemical impurities; it improves efficacy
• Protein aggregation that can reduce potency and increase immunogenicity
• DNA concatemerization; it enhances expression
• Salt crystallization in buffers; it is irrelevant

Correct Answer: Protein aggregation that can reduce potency and increase immunogenicity

Q29. Which in vitro method is used to assess antibody binding kinetics and affinity?

• Surface plasmon resonance (SPR)
• Gel electrophoresis
• Light microscopy
• Mass balance calculations

Correct Answer: Surface plasmon resonance (SPR)

Q30. Which factor is critical when developing a stable liquid formulation for a biopharmaceutical product?

• Selecting appropriate excipients to prevent aggregation and degradation
• Maximizing ionic strength only
• Avoiding any buffer systems
• Using the highest possible protein concentration regardless of stability

Correct Answer: Selecting appropriate excipients to prevent aggregation and degradation

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