In the 2024-25 era of cell culture, what emerging trend is being adopted by Indian biotech companies?
ADiscontinuation of all serum-free media
BAdoption of single-use bioreactors and serum-free, animal-component-free (ACF) media
CReturn to completely manual culture methods
DElimination of quality control testing
Correct Answer:
B. Adoption of single-use bioreactors and serum-free, animal-component-free (ACF) media
EXPLANATION
Modern Indian biotech (2024-25) is shifting toward single-use bioreactors for flexibility, ACF/serum-free media for safety, and automation for consistency in line with global standards.
What is the significance of glucose/lactate ratio monitoring in cell culture?
AIt indicates cell metabolic state and can predict culture performance
BIt determines the shelf life of culture medium
CIt measures contamination levels
DIt controls temperature in the bioreactor
Correct Answer:
A. It indicates cell metabolic state and can predict culture performance
EXPLANATION
The glucose consumption rate and lactate production rate indicate metabolic efficiency. High lactate accumulation suggests metabolic stress and can inhibit cell growth.
How does dissolved oxygen concentration affect cell culture performance?
AHigher DO always increases cell growth rate
BDO above 100% saturation enhances protein production
COptimal DO (typically 30-50% saturation) balances aerobic metabolism and metabolite accumulation
DDO level has no significant effect on mammalian cells
Correct Answer:
C. Optimal DO (typically 30-50% saturation) balances aerobic metabolism and metabolite accumulation
EXPLANATION
While cells need oxygen for respiration, excessive DO can cause oxidative stress. Moderate DO levels (30-50% saturation) optimize growth and reduce lactate accumulation.
What is the consequence of exceeding the maximum viable cell density (MVCD) in a culture system?
ACells enter stationary phase and require more nutrients
BNutrient depletion, waste accumulation, and onset of decline phase with increased cell death
CCells automatically double their doubling time
DEnhanced protein secretion occurs
Correct Answer:
B. Nutrient depletion, waste accumulation, and onset of decline phase with increased cell death
EXPLANATION
Beyond MVCD, limited oxygen, glucose depletion, and accumulation of lactate/ammonia create hostile conditions triggering the decline phase with apoptosis and decreased productivity.
For Indian biotech industries (2024-25) producing therapeutic monoclonal antibodies, which regulatory requirement regarding cell line characterization is mandatory?
ACell line must be >50 years old
BComplete characterization including karyotype, mycoplasma testing, and adventitious agent testing per ICH guidelines
COnly visual inspection is required
DCell line origin documentation is optional
Correct Answer:
B. Complete characterization including karyotype, mycoplasma testing, and adventitious agent testing per ICH guidelines
EXPLANATION
ICH Q5A/Q5B guidelines (followed by India's DCGI) mandate comprehensive cell line characterization including identity verification, sterility, mycoplasma, and viral testing for therapeutic products.
Correct Answer:
B. Dielectric spectroscopy (online capacitance measurement)
EXPLANATION
Dielectric spectroscopy provides real-time, non-invasive measurement of viable cell density by measuring membrane capacitance, enabling immediate process adjustments.
What is the significance of using antifoam agents in large-scale bioreactors?
ATo increase cell proliferation rate
BTo prevent foam formation which can cause cell damage and overflow
CTo replace the need for proper aeration
DTo reduce the viscosity of culture medium
Correct Answer:
B. To prevent foam formation which can cause cell damage and overflow
EXPLANATION
Foam formation in bioreactors during aeration can cause cell lysis, loss of surface area, and carryover into exhaust lines. Antifoam agents (silicone-based) prevent this.
In a perfusion bioreactor system used for continuous cell culture, what is the primary advantage over batch culture?
AIt reduces the need for sterilization
BIt removes waste products and replenishes nutrients continuously, allowing prolonged culture and higher cell densities
CIt completely eliminates the need for temperature control
DIt makes contamination control unnecessary
Correct Answer:
B. It removes waste products and replenishes nutrients continuously, allowing prolonged culture and higher cell densities
EXPLANATION
Perfusion systems continuously exchange medium, removing metabolic wastes and supplying nutrients, enabling higher cell densities and prolonged culture periods compared to batch systems.
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