Production of hormones MCQs With Answer

Production of hormones MCQs With Answer is a focused quiz collection designed for M.Pharm students specializing in Advanced Pharmaceutical Biotechnology. This resource emphasizes practical and theoretical aspects of hormone manufacturing — from gene cloning and host selection to upstream cell culture, downstream purification, and analytical quality control. Each question targets competencies required for designing, scaling, and validating hormone production processes, including recombinant strategies, glycosylation considerations, folding and refolding, bioprocess optimization, and regulatory expectations. These multiple-choice questions, accompanied by clear answers, will help students deepen conceptual understanding and prepare for examinations and real-world problem solving in biopharmaceutical production.

Q1. Which method is most commonly employed for large-scale commercial production of therapeutic peptide and protein hormones?

• Extraction from animal endocrine glands
• Chemical total synthesis
• Recombinant DNA technology in heterologous host systems
• Fermentation by filamentous fungi

Correct Answer: Recombinant DNA technology in heterologous host systems

Q2. For production of heavily glycosylated hormones such as erythropoietin with human-like N-glycans, which host is preferred?

• Escherichia coli
• Saccharomyces cerevisiae
• CHO (Chinese Hamster Ovary) cells
• Bacillus subtilis

Correct Answer: CHO (Chinese Hamster Ovary) cells

Q3. Which signal peptide is commonly used to direct recombinant proteins to the periplasmic space in E. coli to facilitate disulfide bond formation?

• PelB signal peptide
• 6xHis affinity tag
• T7 promoter
• LacZ leader

Correct Answer: PelB signal peptide

Q4. High-level expression of a hormone in E. coli frequently leads to formation of inclusion bodies because:

• The host cell glycosylates proteins incorrectly
• Proteases rapidly degrade the product
• Rapid expression and folding limitations cause aggregation and misfolding
• The secretion machinery in E. coli is too efficient

Correct Answer: Rapid expression and folding limitations cause aggregation and misfolding

Q5. Which engineered E. coli strain improves cytoplasmic disulfide bond formation, enhancing correct folding of disulfide-rich hormones?

• BL21(DE3)
• SHuffle
• DH5α
• JM109

Correct Answer: SHuffle

Q6. What is the primary purpose of codon optimization when designing a hormone gene for expression in a heterologous host?

• To add glycosylation sites compatible with the host
• To increase mRNA secondary structure for stability
• To match host tRNA abundance and improve translation efficiency
• To make the gene shorter for easier cloning

Correct Answer: To match host tRNA abundance and improve translation efficiency

Q7. Which chromatographic technique is the first-choice capture step for a recombinant hormone carrying a polyhistidine tag?

• Ion-exchange chromatography
• Immobilized metal affinity chromatography (IMAC)
• Size-exclusion chromatography
• Hydrophobic interaction chromatography

Correct Answer: Immobilized metal affinity chromatography (IMAC)

Q8. A robust method for reducing endotoxin levels in hormone preparations produced in E. coli is:

• Protein A affinity chromatography
• Triton X-114 phase separation for endotoxin removal
• Simple dialysis against PBS
• Heating at 60°C for 30 minutes

Correct Answer: Triton X-114 phase separation for endotoxin removal

Q9. PEGylation of a therapeutic hormone primarily provides which advantage?

• Increases glycosylation heterogeneity
• Enhances renal clearance
• Prolongs circulating half-life and often reduces immunogenicity
• Creates new proteolytic cleavage sites

Correct Answer: Prolongs circulating half-life and often reduces immunogenicity

Q10. How does glycosylation typically influence the properties of a peptide hormone?

• Has no effect on stability or activity
• Decreases solubility and increases aggregation risk
• Can modulate stability, receptor affinity, immunogenicity and pharmacokinetics
• Always abolishes biological activity

Correct Answer: Can modulate stability, receptor affinity, immunogenicity and pharmacokinetics

Q11. Which analytical approach directly measures the biological potency of a recombinant growth hormone preparation?

• ELISA quantification of antigen concentration
• SDS-PAGE followed by Coomassie staining
• Cell-based receptor activation bioassay (e.g., STAT5 reporter assay)
• Reverse-phase HPLC for purity

Correct Answer: Cell-based receptor activation bioassay (e.g., STAT5 reporter assay)

Q12. For very high-level transcription in an E. coli expression system using T7 RNA polymerase, which promoter is commonly used?

• CMV promoter
• T7 promoter
• GAL1 promoter
• AOX1 promoter

Correct Answer: T7 promoter

Q13. What is a key advantage of using mammalian cell expression systems (e.g., CHO cells) over bacterial systems for many therapeutic hormones?

• Mammalian cells grow faster and are cheaper to culture
• Mammalian systems eliminate the need for downstream purification
• Mammalian cells provide authentic post-translational modifications and proper folding for biologically active glycoproteins
• Mammalian systems always give higher yields per liter than bacteria

Correct Answer: Mammalian cells provide authentic post-translational modifications and proper folding for biologically active glycoproteins

Q14. In upstream bioprocessing for hormone production, the main advantage of a fed-batch culture over a simple batch culture is:

• Fed-batch eliminates the need for sterilization
• Fed-batch maintains optimal nutrient levels to achieve higher cell densities and product yields
• Fed-batch always produces purer protein without downstream steps
• Fed-batch requires no monitoring of pH or DO

Correct Answer: Fed-batch maintains optimal nutrient levels to achieve higher cell densities and product yields

Q15. Which downstream step is typically used as a polishing stage to remove aggregates and achieve final size-based separation of a hormone product?

• Protein A affinity chromatography
• Size-exclusion chromatography (SEC)
• Immobilized metal affinity chromatography (IMAC)
• Capture by ion-exchange

Correct Answer: Size-exclusion chromatography (SEC)

Q16. Which viral inactivation method is commonly incorporated into downstream processes for mammalian-cell-derived hormone products to ensure viral safety?

• Low pH incubation for viral inactivation
• Autoclaving the product stream
• Exposing product to high UV for extended duration
• Adding glutaraldehyde to the final formulation

Correct Answer: Low pH incubation for viral inactivation

Q17. A widely used recombinant insulin production strategy involves which approach to obtain correctly folded and active insulin?

• Express mature insulin directly with intact disulfide bonds in the cytoplasm
• Express A and B chains separately in yeast and chemically ligate them
• Express proinsulin (single-chain precursor) and perform enzymatic processing and disulfide formation to yield insulin
• Harvest insulin directly from animal pancreases and purify

Correct Answer: Express proinsulin (single-chain precursor) and perform enzymatic processing and disulfide formation to yield insulin

Q18. Which analytical technique is most suitable for detailed structural profiling and relative quantitation of N-linked glycans on a therapeutic glycoprotein hormone?

• UV-visible spectrophotometry
• Mass spectrometry (e.g., LC-MS or MALDI-TOF) glycan analysis
• Native PAGE gel electrophoresis
• Simple Bradford protein assay

Correct Answer: Mass spectrometry (e.g., LC-MS or MALDI-TOF) glycan analysis

Q19. What is the principal role of signal peptide cleavage during secretion of a recombinant hormone expressed with an N-terminal leader sequence?

• To increase molecular weight of the mature hormone
• To localize the protein to inclusion bodies
• To direct the protein to the secretion pathway and produce the mature hormone after leader removal
• To add glycosylation to the N-terminus

Correct Answer: To direct the protein to the secretion pathway and produce the mature hormone after leader removal

Q20. Which ICH guideline specifically addresses viral safety evaluation of biotechnology-derived products (viral safety of biologicals)?

• ICH Q3A (Impurities)
• ICH Q5A(R1) — Viral safety evaluation of biotechnology products
• ICH Q6A (Specifications)
• ICH Q9 (Quality Risk Management)

Correct Answer: ICH Q5A(R1) — Viral safety evaluation of biotechnology products

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