Industrial applications of monoclonal antibodies MCQs With Answer

Introduction: Monoclonal antibodies (mAbs) are cornerstone biologics in modern pharmaceutical industry, spanning therapeutics, diagnostics, and research applications. For M.Pharm students, understanding industrial uses of mAbs involves both scientific and regulatory perspectives — from cell line development, upstream and downstream processing, and purification strategies to formulation, stability, and quality control. This blog presents focused multiple-choice questions that probe key concepts such as antibody engineering, biosimilar development, analytical characterization, conjugation technologies (e.g., ADCs), and manufacturing challenges under GMP. These MCQs are designed to deepen comprehension and prepare students for advanced coursework and industry roles in biopharmaceutical development and production.

Q1. Which chromatography medium is most commonly used for capture purification of therapeutic monoclonal antibodies at industrial scale?

• Ion-exchange resin
• Protein A affinity resin
• Hydrophobic interaction resin
• Size-exclusion gel

Correct Answer: Protein A affinity resin

Q2. What is the primary reason for using Chinese Hamster Ovary (CHO) cells in industrial mAb production?

• Highest growth rate among mammalian cells
• Ability to perform human-like post-translational glycosylation
• Resistance to viral contamination
• Lower cost than bacterial expression systems

Correct Answer: Ability to perform human-like post-translational glycosylation

Q3. Antibody-drug conjugates (ADCs) improve therapeutic index primarily by what mechanism?

• Increasing systemic half-life of payload
• Targeted delivery of cytotoxic payload to antigen-expressing cells
• Reducing immunogenicity of the cytotoxin
• Enhancing antibody Fc-mediated effector function

Correct Answer: Targeted delivery of cytotoxic payload to antigen-expressing cells

Q4. Which analytical method is most appropriate for quantifying mAb glycan heterogeneity?

• SDS-PAGE under reducing conditions
• Hydrophilic interaction liquid chromatography (HILIC) after glycan release
• Ultraviolet (UV) absorbance at 280 nm
• Dynamic light scattering (DLS)

Correct Answer: Hydrophilic interaction liquid chromatography (HILIC) after glycan release

Q5. In biosimilar development, the critical quality attribute most scrutinized by regulators is:

• Primary amino acid sequence
• Color of final formulation
• Packaging design
• Market price compared to innovator

Correct Answer: Primary amino acid sequence

Q6. Which modification to the Fc region is commonly engineered to extend mAb serum half-life?

• Introduction of additional glycosylation sites in Fab
• Mutations that increase neonatal Fc receptor (FcRn) binding
• Deletion of the CH2 domain
• Attachment of a fluorescent probe

Correct Answer: Mutations that increase neonatal Fc receptor (FcRn) binding

Q7. Host cell protein (HCP) removal during downstream processing is critical because HCPs can:

• Enhance product potency
• Increase immunogenicity and affect product stability
• Improve conjugation efficiency
• Act as preservatives in formulation

Correct Answer: Increase immunogenicity and affect product stability

Q8. A common stability concern for therapeutic mAbs during storage is:

• DNA integration into host cells
• Aggregation leading to loss of activity and increased immunogenicity
• Lack of antibiotic resistance
• Spontaneous gene mutation in formulation

Correct Answer: Aggregation leading to loss of activity and increased immunogenicity

Q9. Which in-process assay best assesses the biological potency of a monoclonal antibody during manufacturing?

• Endotoxin assay (LAL)
• Cell-based functional bioassay measuring target neutralization or ADCC
• Bradford protein assay
• pH measurement of the buffer

Correct Answer: Cell-based functional bioassay measuring target neutralization or ADCC

Q10. Pegylation of antibodies is performed primarily to:

• Increase binding affinity to antigen
• Reduce immunogenicity and extend circulation time
• Improve chromatographic separation during purification
• Facilitate site-specific glycosylation analysis

Correct Answer: Reduce immunogenicity and extend circulation time

Q11. Which regulatory guideline is most relevant for GMP manufacture of monoclonal antibodies?

• ICH Q5E: Comparability of Biotechnological Products
• ICH Q7: Good Manufacturing Practice for Active Pharmaceutical Ingredients
• ICH Q9: Quality Risk Management
• ICH Q6B: Specifications — Test Procedures and Acceptance Criteria for Biotechnological Products

Correct Answer: ICH Q6B: Specifications — Test Procedures and Acceptance Criteria for Biotechnological Products

Q12. In scaling up upstream mAb production, the most critical parameter to control for reproducible product quality is:

• Culture vessel color
• Cell culture process parameters such as pH, dissolved oxygen, and shear
• Ambient lighting in the facility
• Operator height

Correct Answer: Cell culture process parameters such as pH, dissolved oxygen, and shear

Q13. Bispecific antibodies are industrially valuable because they can:

• Bind two distinct antigens or epitopes simultaneously
• Be produced in bacteria without refolding
• Completely eliminate the need for downstream purification
• Serve as a universal preservative

Correct Answer: Bind two distinct antigens or epitopes simultaneously

Q14. Which conjugation chemistry is commonly used for attaching drug payloads to lysine residues of antibodies?

• Maleimide-thiol chemistry
• NHS-ester (N-hydroxysuccinimide) acylation
• Disulfide bridge formation with reduced Fc
• Click chemistry via azide-alkyne cycloaddition exclusively

Correct Answer: NHS-ester (N-hydroxysuccinimide) acylation

Q15. The purpose of a cell bank (master and working) in mAb manufacturing is to:

• Provide a consistent, characterized source of production cells under GMP
• Replace raw materials sourcing
• Act as a final drug product storage
• Increase expression of host cell proteins intentionally

Correct Answer: Provide a consistent, characterized source of production cells under GMP

Q16. Which indicator suggests potential immunogenicity risk in a monoclonal antibody product?

• Presence of high-molecular-weight aggregates
• Low potency in cell-based assay
• Clear colorless solution with correct pH
• High binding affinity to intended antigen

Correct Answer: Presence of high-molecular-weight aggregates

Q17. During downstream polishing steps, which technique is most suitable to remove residual DNA?

• Protein A chromatography
• Anion-exchange chromatography under appropriate conditions
• Isoelectric focusing
• Reverse-phase HPLC under native conditions

Correct Answer: Anion-exchange chromatography under appropriate conditions

Q18. A critical advantage of Fc engineering in industrial mAbs is to:

• Completely prevent all post-translational modifications
• Modulate effector functions such as ADCC or CDC
• Allow expression in prokaryotic systems without folding issues
• Make antibodies resistant to all proteases

Correct Answer: Modulate effector functions such as ADCC or CDC

Q19. Which assay is primarily used to detect and quantify host-cell derived DNA impurities in final mAb products?

• qPCR (quantitative PCR)
• ELISA for total protein
• Capillary isoelectric focusing
• Size-exclusion HPLC for aggregates

Correct Answer: qPCR (quantitative PCR)

Q20. In formulation development of therapeutic mAbs, addition of polysorbate surfactants is intended to:

• Increase antigen-binding affinity
• Reduce surface-induced aggregation and adsorption
• Serve as primary buffer component
• Enhance glycosylation consistency

Correct Answer: Reduce surface-induced aggregation and adsorption

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