Kemwell provides integrated development and manufacturing services for companies that require one-stop solution for mammalian cell-culture based protein therapeutics – monoclonal antibody, bi-specific or multi-specific antibodies, fusion proteins, etc. The team is experienced to undertake end-to-end activities right from cell line development till cGMP clinical manufacturing or even cGMP commercial manufacturing.
Drug Substance cGMP Manufacturing
As one of India’s largest and most preferred contract manufacturer of biologics, Kemwell operates multiple world-class GMP manufacturing facilities for the production of mammalian cell culture based biologics- monoclonal antibodies, fusion proteins, etc. Over 4000L of bioreactor capacity is available for both clinical trials and commercial drug substance supply.
Drug Product cGMP Manufacturing
We provide fully automated final drug product formulation and filling under cGMP conditions as per by the worldwide regulatory agencies including US FDA, EMA, and agencies from other countries or regions such as Japan, Korea, Taiwan, Singapore, Australia and India.