Kemwell Biopharma, a global contract development and manufacturing service provider has entered into an agreement with a European company for the development and manufacture of monoclonal antibody therapeutics. The name of the European company was not disclosed.
Under the agreement, Kemwell will provide a fully integrated solution including technology transfer, process industrialization, scale-up, manufacturing of toxicology materials, cGMP manufacturing of clinical materials and commercial manufacturing for both drug substance and fill & finish in vials from its new state-of-the-art biopharmaceuticals facility in Bengaluru.
“This broad development and manufacturing agreement demonstrates our customers’ confidence in our biotechnical capabilities. Partnering with a number of well-known technology providers, the company l aims to establish itself as a leading player in the one-stop-shop biopharmaceutical contract manufacturing space,” said Anurag Bagaria, managing director, Kemwell.
Our endeavour is to capitalize on the eastern advantage of a cost-friendly environment while offering all the western advantages of quality and innovation. Our over 30-year expertise in the pharmaceutical development and manufacturing space will help us provide high quality services and products at competitive prices to the biotech industry. We are also expecting an inspection from a EMA (European Medicines Agency) for our biopharmaceutical drug substance as well as the fill-finish facility, during the second half of this year, he added.
Early this year, Kemwell successfully completed its US Food and Drug Administration (FDA) inspection at its oral solids manufacturing facility in Bengaluru.
The Bengaluru-based Kemwell is a pure play contract development and manufacturing company. It develops and manufactures biopharmaceuticals for some of the world’s top pharmaceutical companies, including Bayer, Boehringer Ingelheim, GlaxoSmithKline, Merck KGaA, Novartis and Pfizer.