Kemwell Biopharma, a biologics contract development and manufacturing service provider, has signed a contract to manufacture and supply drug substance using its mammalian cell culture plant in India for Phase III clinical trials that will be conducted in the U.S. by its customer for a BLA filing. 
 
Kemwell provided the customer with technology transfer, process optimization, scale-up, manufacturing of toxicology materials and cGMP manufacturing of drug substance clinical materials, and release testing for the on-going Phase I trials in the U.S. 
 
“We are very excited in taking the project to the next stage and supporting our customer for their Phase III supplies and the BLA filing in the US. As we are seeing a great increase in large molecules in the pipelines of biopharma companies, we believe Kemwell is ideally suited to provide high quality development and manufacturing services at significantly lower costs to support a fast track to GLP tox studies and cGMP clinical and commercial supplies,” says Kemwell’s Chairman, Anurag Bagaria. 
 
Kemwell’s biotechnology capabilities include process development and manufacturing of drug substances and drug products for toxicology supplies 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.