Biologics GMP Manufacturing:
Single-Use Bioreactor Drug Substance Production

Infrastructure

Facility design and capacity

Aragen offers an integrated gene-to-GMP platform for biologics development and manufacturing, combining cell line development, process and analytical development, and clinical and commercial GMP manufacturing capabilities. As of 31 March 2026, our installed GMP manufacturing capacity for Biologics D&M was 2.50 KL, supported by upstream process development and quality-control capabilities. The facility supports products with titers ranging from less than 1 g/L to 12 g/L and is designed for flexible, multi-product operations. Supported by our biologics R&D facility in the San Francisco Bay Area, California, and our development and manufacturing infrastructure in India, this model provides continuity across the biologics value chain.

Advanced technologies

• The facility includes capabilities for biologics development and manufacturing based on 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.

Learn more on the Aragen Bioscience site