Kemwell Biopharma has signed an agreement with a European company for the development and manufacture of monoclonal antibody therapeutics. Kemwell will provide 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 Kemwell’s new facility in Bangalore, India.
Kemwell’s managing director, Anurag Bagaria, remarked, “This broad development and manufacturing agreement demonstrates our customers’ confidence in Kemwell’s biotechnical capabilities." Mr. Bagaria noted that Kemwell is expecting an inspection from a European agency for its biopharma drug substance and fill/finish facility during the second half of the year.
In 2008, Kemwell entered into a strategic collaboration with Boehringer Ingelheim, and its biopharma facilities have been designed with the engineering and operational support of BI.