Kemwell Biopharma signs development and manufacturing agreement for mAb therapeutics

Published: 19-Sep-2013

Company will provide a fully integrated solution to a European manufacturer from its Bangalore biopharma facility

Kemwell Biopharma, a global contract development and manufacturing service provider based in Bangalore, India, has signed an agreement with a European company for the development and manufacture of monoclonal antibody therapeutics.

Kemwell will provide a fully integrated solution including technology transfer, process industrialisation, scale-up, manufacturing of toxicology materials, cGMP manufacturing of clinical materials and commercial manufacturing for both drug substance and fill and finish in vials from Kemwell's new state-of-the-art biopharmaceuticals facility in Bangalore, India.

'This broad development and manufacturing agreement demonstrates our customers' confidence in Kemwell's biotechnical capabilities,' said Managing Director Anurag Bagaria. 'Our endeavour is to capitalise on the eastern advantage of a cost-friendly environment while offering all the western advantages of quality and innovation.

'We are also expecting an inspection from a European agency for our biopharmaceutical drug substance as well as fill-finish facility, during the second half of this year.'

In 2008, Kemwell entered into a strategic collaboration with Boehringer Ingelheim, Germany. These facilities have been designed with the engineering and operational support of Boehringer Ingelheim. Kemwell's biotechnology capabilities now 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 lyophilised vials and integrated quality management.

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