Aragen, a contract research, development and manufacturing organisation (CRDMO), announced that it will commence GMP manufacturing at its biologics manufacturing facility in Bangalore, India from July 2025.
Aragen
Aragen has successfully completed the facility and equipment qualification and demonstrated the productivity of its intensified fed batch cell culture manufacturing platform to deliver titers >25 g/L.
The news, released ahead of BIO Boston, comes on the back of several successful pharma customer audits with more biotech discussions expected to accelerate at the event.
The facility opens with the flexibility to house multiple 2KL Single use bioreactors, set up for both fed batch and intensified fed batch production and can deliver one batch every 4-5 days at full capacity. Significantly, the bioreactors are configured with multiple 2KL units feeding into a single downstream purification suite. This provides flexibility to run multiple client projects in parallel or quickly scale up a customer’s production to commercial quantities.
“The Aragen team has delivered a state-of-the-art facility to enable industry leading COGS and quality. Our first customer program will progress to GMP production as early as late July this year. The Bangalore manufacturing facility will help seamless transition to GMP manufacturing using not only intensified fed batch production, but also, our proprietary high-yield CHO-GS and CHO-DG44 cell lines,” said Subodh Deshmukh, CEO, biologics and president, development.
Jamie Cascio, AVP, biologics, said: "The biologics manufacturing facility in Bangalore marks a significant milestone in Aragen's evolution as an integrated, end-to-end solutions provider. With cutting-edge infrastructure and deep technical expertise under one roof, this facility is designed to seamlessly support our partners from early discovery through to commercial manufacturing. It strengthens our ability to offer speed, scalability, and compliance — enabling our customers to accelerate the journey of their biologics molecules to market with confidence."
The facility complements Aragen’s existing biologics capabilities in Morgan Hill, California and together will offer integrated services including cell line development, process & analytical development, QC and GMP manufacturing of monoclonal antibodies, biosimilars and other recombinant proteins. The California site already provides non-GMP manufacturing for batches from 1L to 50L across six separate suites.
Aragen has completed more than 200 CLD projects, with over 100 of those cell lines in the clinic after successful IND filings. In fact, several Aragen-developed cell lines are now used by clients for the manufacture of marketed products in the US and worldwide.