Applications of cell cultures in pharmaceutical industry MCQs With Answer

Applications of cell cultures in pharmaceutical industry MCQs With Answer

Cell culture applications in the pharmaceutical industry drive drug discovery, vaccine production, biologics manufacturing, toxicity testing, and quality control. B. Pharm students must master in vitro models, primary and continuous cell lines, sterile technique, cell banking, cGMP requirements, assay methods (MTT, LDH), and bioprocess scale-up. Understanding contamination control, transfection, recombinant protein expression, monoclonal antibody production, and 3D organoids enhances skills for formulation, ADME screening, and regulatory compliance. These MCQs with answers focus on practical workflows, analytical methods, and industry-relevant challenges to build strong conceptual and applied knowledge for pharmaceutical careers. Now let’s test your knowledge with 50 MCQs on this topic.

Q1. Which cell culture system is commonly used for large-scale production of monoclonal antibodies?

  • Primary hepatocyte suspension culture
  • CHO cell fed-batch culture
  • Neuronal organoid static culture
  • Escherichia coli shake flask culture

Correct Answer: CHO cell fed-batch culture

Q2. What is the primary purpose of mycoplasma testing in cell culture labs?

  • To measure endotoxin levels in media
  • To detect bacterial contamination that alters cell physiology
  • To confirm viral clearance for vaccines
  • To assess cell viability by staining

Correct Answer: To detect bacterial contamination that alters cell physiology

Q3. Which assay is most widely used to assess cell metabolic activity as a proxy for viability?

  • Western blot
  • MTT assay
  • PCR for housekeeping genes
  • Electron microscopy

Correct Answer: MTT assay

Q4. What is the advantage of serum-free media for industrial cell culture?

  • Increases risk of mycoplasma
  • Reduces lot-to-lot variability and contamination risk
  • Makes cells immortal automatically
  • Eliminates need for aseptic technique

Correct Answer: Reduces lot-to-lot variability and contamination risk

Q5. Which cell line is a standard mammalian host for recombinant protein expression in pharma?

  • Saccharomyces cerevisiae
  • CHO (Chinese Hamster Ovary) cells
  • RAW 264.7 macrophages
  • BHK-21 bacterial culture

Correct Answer: CHO (Chinese Hamster Ovary) cells

Q6. What does cGMP stand for and why is it important in cell culture manufacturing?

  • current Good Microbiology Practice; for lab cleanliness
  • current Good Manufacturing Practice; ensures product quality and regulatory compliance
  • controlled Growth Media Procedure; for media preparation
  • cell Growth Monitoring Protocol; for cell counting

Correct Answer: current Good Manufacturing Practice; ensures product quality and regulatory compliance

Q7. Which technique is used to create monoclonal antibody-secreting hybridoma cells?

  • Flow cytometry sorting
  • Fusion of B lymphocytes with myeloma cells
  • CRISPR knock-in of Fc region
  • Transient transfection of fibroblasts

Correct Answer: Fusion of B lymphocytes with myeloma cells

Q8. What is a key benefit of 3D spheroid cultures over 2D monolayers in drug testing?

  • Lower cost of reagents
  • Better mimicry of in vivo tissue architecture and gradients
  • Faster growth rates for bacteria
  • Elimination of need for incubators

Correct Answer: Better mimicry of in vivo tissue architecture and gradients

Q9. Which parameter is critical to control in bioreactor upstream processing?

  • Elution buffer composition
  • pH, dissolved oxygen, and temperature
  • Freeze-thaw cycle number
  • Final formulation viscosity

Correct Answer: pH, dissolved oxygen, and temperature

Q10. What is the role of microcarriers in cell culture?

  • To chemically fix cells before staining
  • To provide surface area for adherent cells in suspension bioreactors
  • To act as antibiotics in media
  • To detect endotoxin contamination

Correct Answer: To provide surface area for adherent cells in suspension bioreactors

Q11. Which method is commonly used for long-term storage of cell lines?

  • Room temperature incubation
  • Cryopreservation in liquid nitrogen with cryoprotectant
  • Continuous passaging without freezing
  • Lyophilization of living cells

Correct Answer: Cryopreservation in liquid nitrogen with cryoprotectant

Q12. What is the primary purpose of cell banking (Master Cell Bank) in pharma?

  • To increase cell mutation rates
  • To provide a characterized, stable source for consistent production
  • To test new antibiotics
  • To store media recipes

Correct Answer: To provide a characterized, stable source for consistent production

Q13. Which contamination is most difficult to detect visually in cell cultures?

  • Yeast contamination
  • Mycoplasma contamination
  • Fungal hyphae contamination
  • Algal blooms

Correct Answer: Mycoplasma contamination

Q14. Which transfection method is suitable for transient expression in mammalian cells?

  • Electroporation or lipid-mediated transfection
  • Heat shock transformation
  • Chemical competence induction used in bacteria
  • Solid-phase peptide synthesis

Correct Answer: Electroporation or lipid-mediated transfection

Q15. What is the significance of STR profiling for cell lines?

  • Measures cell metabolic activity
  • Authenticates cell line identity and prevents cross-contamination
  • Determines appropriate media composition
  • Detects viral particles in culture

Correct Answer: Authenticates cell line identity and prevents cross-contamination

Q16. Which in vitro model is most appropriate for hepatic metabolism studies?

  • Primary hepatocytes or HepaRG cells
  • CHO cells
  • Keratinocyte monolayers
  • Neural stem cells

Correct Answer: Primary hepatocytes or HepaRG cells

Q17. What does LDH release assay measure in cytotoxicity testing?

  • DNA fragmentation
  • Cell membrane integrity via released lactate dehydrogenase
  • Mitochondrial respiration directly
  • Intracellular ATP concentration

Correct Answer: Cell membrane integrity via released lactate dehydrogenase

Q18. Which regulatory guideline is most relevant for biologics produced from cell culture?

  • ICH Q7 for APIs manufactured by chemical synthesis
  • ICH Q5A/B for quality of biotechnology-derived products
  • USP chapter on tablet dissolution only
  • ISO 9001 for construction materials

Correct Answer: ICH Q5A/B for quality of biotechnology-derived products

Q19. What is the main challenge addressed by serum reduction or replacement in media?

  • Improving viral infectivity
  • Reducing variability and risk of adventitious agents
  • Increasing mycoplasma contamination
  • Preventing cell attachment entirely

Correct Answer: Reducing variability and risk of adventitious agents

Q20. Which technique is used for quantifying viable cells in culture quickly?

  • Colony PCR
  • Trypan blue exclusion with hemocytometer or automated counter
  • Western blot for actin
  • ELISA for secreted cytokines

Correct Answer: Trypan blue exclusion with hemocytometer or automated counter

Q21. What is the purpose of perfusion culture in bioprocessing?

  • To continuously remove waste and supply fresh medium for high-density culture
  • To dry cultures for storage
  • To genetically modify cells during growth
  • To perform batch fermentation of bacteria

Correct Answer: To continuously remove waste and supply fresh medium for high-density culture

Q22. Which quality attribute is critical for therapeutic proteins produced in cell culture?

  • Sequence variant and glycosylation profile consistency
  • Color of culture medium
  • Number of flasks used in culture
  • pH of the final packaging box

Correct Answer: Sequence variant and glycosylation profile consistency

Q23. How does CRISPR/Cas9 technology contribute to cell culture applications in pharma?

  • It sterilizes culture media
  • Enables precise genome editing for disease models and improved production strains
  • Replaces the need for incubators
  • Measures protein concentration in supernatant

Correct Answer: Enables precise genome editing for disease models and improved production strains

Q24. Which assay is best for high-throughput screening of cytotoxic compounds?

  • Long-form histology staining
  • ATP-based luminescence assays
  • Sanger sequencing of treated cells
  • Chromatography of cell lysates

Correct Answer: ATP-based luminescence assays

Q25. What is the role of endotoxin testing for cell-culture derived products?

  • To measure DNA contamination
  • To detect lipopolysaccharide from Gram-negative bacteria that can cause pyrogenic reactions
  • To quantify viral particles
  • To assess cell viability

Correct Answer: To detect lipopolysaccharide from Gram-negative bacteria that can cause pyrogenic reactions

Q26. Which feature distinguishes primary cell cultures from immortalized cell lines?

  • Primary cells have unlimited proliferative capacity
  • Primary cells are directly isolated from tissue and have limited lifespan
  • Immortalized lines cannot be cultured in vitro
  • Primary cells are resistant to contamination

Correct Answer: Primary cells are directly isolated from tissue and have limited lifespan

Q27. In scale-up, what does the term ‘kLa’ refer to and why is it important?

  • Heat transfer coefficient; important for cooling
  • Volumetric oxygen transfer coefficient; critical for oxygen supply to cells
  • Rate of media consumption; for cost estimation
  • Number of passages per week; for cell aging

Correct Answer: Volumetric oxygen transfer coefficient; critical for oxygen supply to cells

Q28. Which downstream process is commonly used to purify monoclonal antibodies from culture supernatant?

  • Protein A affinity chromatography
  • Salt precipitation only
  • Size-exclusion of whole cells
  • Lyophilization of supernatant

Correct Answer: Protein A affinity chromatography

Q29. What is the significance of passage number for a cell line in experiments?

  • Higher passage always increases productivity
  • Passage number can affect cell phenotype, genetic drift, and reproducibility
  • Passage number indicates contamination level only
  • Passage number is unrelated to experimental outcomes

Correct Answer: Passage number can affect cell phenotype, genetic drift, and reproducibility

Q30. Which sterility practice is essential when handling cell cultures?

  • Wearing street clothes in the hood
  • Working inside a certified biosafety cabinet with aseptic technique
  • Always opening petri dishes to air for equilibration
  • Reusing disposable pipette tips

Correct Answer: Working inside a certified biosafety cabinet with aseptic technique

Q31. What does ‘anchorage-independent growth’ indicate about a cell line?

  • Cells require attachment to proliferate
  • Cells can grow without a substrate and may exhibit transformed or tumorigenic properties
  • Cells only survive in primary culture
  • Cells cannot be used for drug testing

Correct Answer: Cells can grow without a substrate and may exhibit transformed or tumorigenic properties

Q32. Which control strategy improves consistency in bioreactor runs using PAT (Process Analytical Technology)?

  • Random sampling without analysis
  • Real-time monitoring of critical parameters and feedback control
  • Ignoring sensor drift
  • Manual adjustments based on operator intuition only

Correct Answer: Real-time monitoring of critical parameters and feedback control

Q33. For vaccine production using cell culture, which safety measure is most critical during scale-up?

  • Using uncharacterized serum
  • Validation of viral inactivation and removal steps, and containment strategies
  • Skipping sterility testing to save time
  • Pooling unknown donor cells without testing

Correct Answer: Validation of viral inactivation and removal steps, and containment strategies

Q34. Which indicator would suggest contamination with filamentous fungi in culture?

  • Clear, colorless medium with normal cell morphology
  • Floating mycelial mats or fuzzy colonies in culture
  • Only a subtle increase in pH
  • Complete clarity and sterility

Correct Answer: Floating mycelial mats or fuzzy colonies in culture

Q35. What is the main use of co-culture systems in pharmaceutical research?

  • To culture bacteria only
  • To model cell–cell interactions and more physiologically relevant responses
  • To simplify single-cell assays
  • To avoid using permeable supports

Correct Answer: To model cell–cell interactions and more physiologically relevant responses

Q36. Which measurement is commonly used to determine protein expression yield in culture supernatant?

  • Nitrogen gas content
  • ELISA or HPLC quantification of target protein
  • Cell diameter measurement
  • pH meter reading

Correct Answer: ELISA or HPLC quantification of target protein

Q37. Why is validation of analytical assays important in cell-culture derived product testing?

  • To increase batch-to-batch variability
  • To ensure accuracy, precision, specificity, and regulatory acceptance
  • To eliminate the need for controls
  • To bypass stability testing

Correct Answer: To ensure accuracy, precision, specificity, and regulatory acceptance

Q38. Which technique is used to detect viral contamination in cell lines?

  • Microscopy for bacterial rods only
  • PCR-based assays or viral antigen detection methods
  • MTT viability assay only
  • Protein A chromatography

Correct Answer: PCR-based assays or viral antigen detection methods

Q39. What is the role of feeder layers in some primary cell cultures?

  • Provide mechanical agitation
  • Support growth by providing extracellular factors and attachment substrate
  • Act as the main source of contamination
  • Reduce oxygen supply intentionally

Correct Answer: Support growth by providing extracellular factors and attachment substrate

Q40. In cell culture-derived drug screening, what is ADME in vitro modeling used for?

  • Assessing taste and color of formulations
  • Predicting absorption, distribution, metabolism, and excretion properties
  • Measuring only cell density
  • Calculating batch yield in grams

Correct Answer: Predicting absorption, distribution, metabolism, and excretion properties

Q41. Which cell-based reporter assay can indicate activation of a specific signaling pathway?

  • Use of luciferase reporter under pathway-specific promoter
  • Gram staining of cultures
  • Endotoxin LAL test
  • Protein A purification

Correct Answer: Use of luciferase reporter under pathway-specific promoter

Q42. What is the primary consideration when choosing a host cell for recombinant protein with human-like glycosylation?

  • Cost alone
  • Glycosylation machinery similarity to human cells, such as CHO or human cell lines
  • Ability to grow only in bacteria
  • Resistance to freezing

Correct Answer: Glycosylation machinery similarity to human cells, such as CHO or human cell lines

Q43. Which method helps detect cross-contamination between cell lines?

  • Routine light microscopy only
  • STR profiling and karyotyping
  • MTT assay
  • Protein quantification in media

Correct Answer: STR profiling and karyotyping

Q44. What is a major advantage of adherent suspension-adapted cell lines for manufacturing?

  • They cannot be cultured in bioreactors
  • They allow high-density growth in suspension bioreactors and scalable production
  • They always require serum
  • They eliminate the need for downstream purification

Correct Answer: They allow high-density growth in suspension bioreactors and scalable production

Q45. Which parameter is essential to monitor during cell thawing from cryopreservation?

  • Time and temperature to minimize osmotic shock and maximize viability
  • Amount of air in storage box
  • Electrical conductivity of cryovial cap
  • Color of the cryoprotectant only

Correct Answer: Time and temperature to minimize osmotic shock and maximize viability

Q46. How does serum supplementation affect recombinant protein glycosylation?

  • Has no effect on glycosylation
  • Can influence glycosylation patterns through varying factors and nutrients
  • Makes proteins invisible to assays
  • Automatically humanizes all glycoforms

Correct Answer: Can influence glycosylation patterns through varying factors and nutrients

Q47. What is the consequence of high shear stress in bioreactors for sensitive mammalian cells?

  • Increased protein folding efficiency
  • Cell damage, reduced viability, and lower product yield
  • Automatic elimination of contamination
  • Improved viral clearance only

Correct Answer: Cell damage, reduced viability, and lower product yield

Q48. Which approach improves reproducibility of cell-based assays across labs?

  • Using unstandardized cell sources
  • Implementing standardized protocols, reference controls, and documented SOPs
  • Ignoring incubation times
  • Varying reagent suppliers frequently

Correct Answer: Implementing standardized protocols, reference controls, and documented SOPs

Q49. Which factor is crucial for successful transient transfection for protein production?

  • Choice of transfection reagent, DNA quality, and cell health
  • Length of cryostorage only
  • Using bacteria instead of mammalian cells
  • High endotoxin in plasmid prep

Correct Answer: Choice of transfection reagent, DNA quality, and cell health

Q50. Why are organoids becoming important models in pharmaceutical research?

  • They are 2D monolayers that simplify analysis
  • They recapitulate multicellular architecture and function for disease modeling and drug screening
  • They eliminate the need for any quality control
  • They are identical to immortalized cell lines in all respects

Correct Answer: They recapitulate multicellular architecture and function for disease modeling and drug screening

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