New era drug products – opportunities and challenges MCQs With Answer

Introduction: New era drug products — opportunities and challenges MCQs With Answer is designed for M.Pharm students to deepen understanding of modern therapeutic modalities and the associated development and technology transfer complexities. This collection focuses on advanced products such as biologics, biosimilars, gene and cell therapies, mRNA vaccines, nanomedicines, and 3D-printed dosage forms. Questions emphasize CMC, scale-up, regulatory expectations, quality by design, analytical comparability, cold-chain logistics, and safety concerns like immunogenicity. The MCQs aim to prepare students for both academic exams and practical challenges in industry by integrating scientific, regulatory, and manufacturing perspectives crucial for successful development and commercialization of next-generation drug products.

Q1. Which of the following best describes “new era drug products” in contemporary pharmaceutical development?

• Traditional small-molecule chemical entities manufactured by batch processing
• Vaccines only, produced by classical egg-based methods
• Biologics, gene and cell therapies, mRNA products, nanomedicines and advanced delivery systems
• Only over-the-counter herbal supplements and nutraceuticals

Correct Answer: Biologics, gene and cell therapies, mRNA products, nanomedicines and advanced delivery systems

Q2. Which regulatory concept is most critical when changing a manufacturing site for a biologic during technology transfer?

• Color matching of packaging labels
• Comparability demonstrating that product quality, safety and efficacy remain unchanged
• Switching to a different API supplier without documentation
• Changing the product indication to avoid testing

Correct Answer: Comparability demonstrating that product quality, safety and efficacy remain unchanged

Q3. In the context of biologics, what does “critical quality attribute (CQA)” refer to?

• An aesthetic feature like bottle shape
• A property that must be measured for marketing purposes only
• A physical, chemical, biological or microbiological property that should be within limits to ensure product quality
• A shipping label requirement

Correct Answer: A physical, chemical, biological or microbiological property that should be within limits to ensure product quality

Q4. Which analytical approach is essential for establishing biosimilarity between a biosimilar and its reference product?

• Single-point potency assay alone
• Comprehensive orthogonal physicochemical and functional characterization
• Visual inspection of vials only
• Relying solely on post-marketing safety reports

Correct Answer: Comprehensive orthogonal physicochemical and functional characterization

Q5. A major challenge for mRNA therapeutics compared with small molecules is:

• Lower molecular weight leading to faster diffusion
• Requirement for cold-chain storage and delivery systems to protect stability
• No need for delivery vehicles because mRNA is cell-permeable
• Complete absence of immunogenicity concerns

Correct Answer: Requirement for cold-chain storage and delivery systems to protect stability

Q6. During scale-up of a cell therapy process, which parameter is most likely to affect cell phenotype and potency?

• Font type on batch records
• Culture vessel geometry, shear stress and oxygen transfer rates
• Room paint color in the facility
• Barcode scanner brand

Correct Answer: Culture vessel geometry, shear stress and oxygen transfer rates

Q7. Which technology enables personalized drug dosage forms tailored to individual patient anatomy or dose requirements?

• High-throughput screening
• 3D printing (additive manufacturing) of pharmaceuticals
• Traditional tablet compression without modification
• Gas chromatography for API analysis

Correct Answer: 3D printing (additive manufacturing) of pharmaceuticals

Q8. Which of the following is a primary regulatory concern unique to gene therapies?

• Color stability of the label
• Long-term biodistribution, persistence and insertional mutagenesis risk
• Tablet dissolution rate in water
• Choice of perfume in packaging

Correct Answer: Long-term biodistribution, persistence and insertional mutagenesis risk

Q9. In technology transfer, a Master Cell Bank (MCB) characterization should include:

• Only cell count at thaw
• Identity, sterility, adventitious agents testing, genetic stability and viability
• Packaging artwork approval
• Marketing strategy for the cell therapy

Correct Answer: Identity, sterility, adventitious agents testing, genetic stability and viability

Q10. Which manufacturing approach can improve control and consistency for new era biologics compared to traditional batch methods?

• Open non-automated bench processing
• Continuous manufacturing with real-time monitoring (PAT)
• Hand-labeling of containers
• Relying solely on end-product testing without process control

Correct Answer: Continuous manufacturing with real-time monitoring (PAT)

Q11. What is a major analytical challenge when assessing nanoparticle-based drug products?

• Measuring the font size on the label
• Characterizing size distribution, surface charge, encapsulation efficiency and release profile
• Only weighing the bulk product is sufficient
• Testing taste as the primary quality attribute

Correct Answer: Characterizing size distribution, surface charge, encapsulation efficiency and release profile

Q12. Which concept of Quality by Design (QbD) is especially useful during development of complex biologics?

• Ignoring process variability to expedite release
• Defining a design space and controlling critical process parameters linked to CQAs
• Designing only for the cheapest raw materials
• Establishing arbitrary acceptance criteria without risk assessment

Correct Answer: Defining a design space and controlling critical process parameters linked to CQAs

Q13. For a biosimilar, which clinical requirement is typically reduced due to extensive analytical comparability?

• All manufacturing controls can be removed
• Large efficacy trials may be abbreviated, focusing on targeted PK/PD and immunogenicity studies
• No need to file any regulatory dossier
• Post-marketing surveillance can be skipped entirely

Correct Answer: Large efficacy trials may be abbreviated, focusing on targeted PK/PD and immunogenicity studies

Q14. Which is a common stability concern for protein therapeutics during storage and transport?

• Improved potency with time
• Aggregation, deamidation, oxidation and loss of activity influenced by temperature and container interactions
• Increase in color vibrancy over time
• Spontaneous conversion into a small-molecule API

Correct Answer: Aggregation, deamidation, oxidation and loss of activity influenced by temperature and container interactions

Q15. What is a key advantage of lipid nanoparticle (LNP) delivery systems for nucleic acid drugs?

• They make nucleic acids heavier for easier dosing
• Protection from nuclease degradation and facilitation of cellular uptake and endosomal escape
• They eliminate the need for cold storage
• They automatically reduce immunogenicity to zero

Correct Answer: Protection from nuclease degradation and facilitation of cellular uptake and endosomal escape

Q16. During tech transfer, establishing critical process parameters (CPPs) helps primarily to:

• Determine the color of the production hall
• Ensure consistent product quality by controlling variables that affect CQAs
• Reduce the size of analytical labs
• Avoid documentation of process changes

Correct Answer: Ensure consistent product quality by controlling variables that affect CQAs

Q17. Which immunogenicity-related risk must be actively monitored for therapeutic proteins and biologics?

• Packaging misprints
• Anti-drug antibody (ADA) formation that can neutralize efficacy or cause adverse reactions
• Change in tablet hardness
• Increased sweetness over time

Correct Answer: Anti-drug antibody (ADA) formation that can neutralize efficacy or cause adverse reactions

Q18. What challenge is specific to transferring analytical methods for complex biologics between labs?

• Only the analyst’s handwriting changes
• Method robustness, instrument qualification, reference standards and inter-laboratory variability must be addressed
• Analytical methods for biologics never need validation
• Only temperature of the lab matters while everything else remains constant

Correct Answer: Method robustness, instrument qualification, reference standards and inter-laboratory variability must be addressed

Q19. Which documentation is essential as part of technology transfer package for a new era drug product?

• Only marketing brochures
• Comprehensive process descriptions, control strategies, batch records, analytical methods and validation data
• Only financial projections
• Only vendor logos and color schemes

Correct Answer: Comprehensive process descriptions, control strategies, batch records, analytical methods and validation data

Q20. Which strategy helps mitigate cold-chain failures for temperature-sensitive biologics?

• Using unvalidated coolers without monitoring
• Implementing validated thermal packaging, real-time temperature monitoring and risk-based distribution controls
• Shipping at ambient temperature without qualification
• Relying solely on end-user refrigeration practices

Correct Answer: Implementing validated thermal packaging, real-time temperature monitoring and risk-based distribution controls

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