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Kemwell Biopharma successfully supplies drug substance prepared from mammalian cell culture to a USA-based customer


Kemwell Biopharma says that it has successfully manufactured and supplied drug substance using its mammalian cell culture plant in India for clinical trials that will be performed by its customer in USA for an IND filing.

By Team ABLE

Kemwell Biopharma, a contract development and manufacturing service provider located in Bengaluru, announced that it has manufactured and supplied drug substance using its 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.

Kemwell says that it has 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. 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,\" commented Kemwell\'s Managing Director, Anurag Bagaria.

Bagaria further explained that Kemwell now 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 and finish in liquid and lyophilized vials and integrated quality management.