Govt. Exams
Entrance Exams
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.
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.
The glucose consumption rate and lactate production rate indicate metabolic efficiency. High lactate accumulation suggests metabolic stress and can inhibit cell growth.
While cells need oxygen for respiration, excessive DO can cause oxidative stress. Moderate DO levels (30-50% saturation) optimize growth and reduce lactate accumulation.
Beyond MVCD, limited oxygen, glucose depletion, and accumulation of lactate/ammonia create hostile conditions triggering the decline phase with apoptosis and decreased productivity.
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.
Dielectric spectroscopy provides real-time, non-invasive measurement of viable cell density by measuring membrane capacitance, enabling immediate process adjustments.
Fed-batch feeding strategies prevent nutrient depletion and byproduct accumulation, extending productive culture phases and improving final product titers compared to batch culture.
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.
Perfusion systems continuously exchange medium, removing metabolic wastes and supplying nutrients, enabling higher cell densities and prolonged culture periods compared to batch systems.
