Kemwell supplies biologics drug substance for phase 1 Clinical Trials for U.S IND filing

Kemwell Biopharma announced that it has manufactured and supplied drug substance using its state-of-the-art mammalian cell culture plant in India for clinical trials that will be performed by its customer in the U.S. for an IND filing. The customer has received IND approval and is commencing Phase 1 clinical trials.

Kemwell provided a fully integrated solution including technology transfer, process optimization, scale-up, manufacturing of toxicology materials and cGMP manufacturing of drug substance clinical materials.

Kemwell MD, Anurag Bagaria  Partnering with a number of well-known technology providers, Kemwell aims to establish itself as a leading player in the one-stop-shop biopharmaceutical contract manufacturing space. Their endeavor is to capitalize on the eastern advantage of a cost-friendly environment while offering all the western advantages of quality and innovation. As pharmaceutical companies are now concentrating their R&D budgets on large molecule products, they are seeing increased demand in their biotech services.