Biotechnology - MCQ Practice Questions

Dielectric spectroscopy provides real-time, non-invasive measurement of viable cell density by measuring membrane capacitance, enabling immediate process adjustments.

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.

Beyond MVCD, limited oxygen, glucose depletion, and accumulation of lactate/ammonia create hostile conditions triggering the decline phase with apoptosis and decreased productivity.

While cells need oxygen for respiration, excessive DO can cause oxidative stress. Moderate DO levels (30-50% saturation) optimize growth and reduce lactate accumulation.

The glucose consumption rate and lactate production rate indicate metabolic efficiency. High lactate accumulation suggests metabolic stress and can inhibit cell growth.

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.

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.