GMP Manufacturing

Infrastructure

Facility design and capacity

The Process Development laboratory will have bioreactors of 50 L to 2000 L capacity with associated purification equipment; expansion to 5000 L. The manufacturing facility will have multiple single-use bioreactors of up to 2KL capacity. The facility is designed to ramp up manufacturing capacities to more than 20 KL with a maximum bioreactor scale of 5 KL. It will provide GMP manufacturing from 2L to 2 KL in the initial phase and ramping up to 5 KL. The manufacturing facility will be handling products with titers <1g/L to 12 g/L using a single-use platform for easy, flexible, and efficient multi-product operations.

Advanced technologies

• The facility will develop and manufacture biologics on high-performing cell culture platforms.
• Support the development to manufacturing of formulated drug substances including the generation and long-term storage of MCB/WCB.
• Manage platforms like fed-batch, continuous and intensified processes for high throughput production for upstream and downstream processes at clinical to commercial scale.
• Continuous chromatography system and single-use membrane chromatography, as an alternative to resin-based purification, towards cost and throughput optimization.

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