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Biotechnology

Genetic engineering, fermentation, cell biology

67 Q 3 Topics Take Mock Test
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Q.1 Hard Cell Culture
Which parameter is MOST critical to monitor in a GMP-compliant mammalian cell culture facility?
A Color of the culture medium
B Viable cell density, viability, and product concentration with real-time process monitoring
C Employee attendance records
D Ambient room temperature only
Correct Answer:  B. Viable cell density, viability, and product concentration with real-time process monitoring
EXPLANATION

GMP compliance requires continuous monitoring of critical quality attributes (CQAs): viable cell density, viability percentage, and product titer. Real-time monitoring ensures batch consistency and safety.

Test
Q.2 Hard Cell Culture
In the 2024-25 era of cell culture, what emerging trend is being adopted by Indian biotech companies?
A Discontinuation of all serum-free media
B Adoption of single-use bioreactors and serum-free, animal-component-free (ACF) media
C Return to completely manual culture methods
D Elimination 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.

Test
Q.3 Hard Cell Culture
What is the significance of glucose/lactate ratio monitoring in cell culture?
A It indicates cell metabolic state and can predict culture performance
B It determines the shelf life of culture medium
C It measures contamination levels
D It 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.

Test
Q.4 Hard Cell Culture
How does dissolved oxygen concentration affect cell culture performance?
A Higher DO always increases cell growth rate
B DO above 100% saturation enhances protein production
C Optimal DO (typically 30-50% saturation) balances aerobic metabolism and metabolite accumulation
D DO 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.

Test
Q.5 Hard Cell Culture
What is the consequence of exceeding the maximum viable cell density (MVCD) in a culture system?
A Cells enter stationary phase and require more nutrients
B Nutrient depletion, waste accumulation, and onset of decline phase with increased cell death
C Cells automatically double their doubling time
D Enhanced 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.

Test
Q.6 Hard Cell Culture
For Indian biotech industries (2024-25) producing therapeutic monoclonal antibodies, which regulatory requirement regarding cell line characterization is mandatory?
A Cell line must be >50 years old
B Complete characterization including karyotype, mycoplasma testing, and adventitious agent testing per ICH guidelines
C Only visual inspection is required
D Cell 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.

Test
Q.7 Hard Cell Culture
Which method is most suitable for real-time monitoring of cell viability in a bioreactor during fermentation?
A Manual hemocytometer counting once daily
B Dielectric spectroscopy (online capacitance measurement)
C Quarterly flow cytometry analysis
D Visual microscopy inspection
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.

Test
Q.8 Hard Cell Culture
In the fed-batch culture strategy, the primary advantage over batch culture is:
A Requires no monitoring equipment
B Extended culture duration with controlled nutrient feeding maintains high cell viability and productivity
C Produces higher quality proteins than continuous culture
D Eliminates all metabolic byproducts
Correct Answer:  B. Extended culture duration with controlled nutrient feeding maintains high cell viability and productivity
EXPLANATION

Fed-batch feeding strategies prevent nutrient depletion and byproduct accumulation, extending productive culture phases and improving final product titers compared to batch culture.

Test
Q.9 Hard Cell Culture
What is the significance of using antifoam agents in large-scale bioreactors?
A To increase cell proliferation rate
B To prevent foam formation which can cause cell damage and overflow
C To replace the need for proper aeration
D To 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.

Test
Q.10 Hard Cell Culture
In a perfusion bioreactor system used for continuous cell culture, what is the primary advantage over batch culture?
A It reduces the need for sterilization
B It removes waste products and replenishes nutrients continuously, allowing prolonged culture and higher cell densities
C It completely eliminates the need for temperature control
D It 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.

Test

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