Kemwell Biopharma announced 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 USA for an IND filing. The customer has received IND approval and is commencing Phase 1 clinical trials.
Mammalian cell culture production facility with 2000l bioreactors
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.
"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,” Kemwell's Managing Director, Anurag Bagaria said. Our 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, we are seeing increased demand in our biotech services.”
Kemwell has a strong team with senior scientists trained in USA and in-depth knowledge and technical expertise on development of new biological entities (NBE's), biosimilars and bio-betters. Their biotechnology capabilities include process development and manufacturing of drug substances and drug products for toxicology in 80L scale bioreactors, as well as for cGMP clinical and commercial manufacturing in 400L and 2000L bioreactors with corresponding downstream processing, fill & finish in liquid and lyophilized vials and integrated quality management.