Biopharmaceutical Drug Substance
Kemwell offers full service contract biopharmaceutical process development, manufacturing, formulation, and fill-finish capabilities at our newest 15,000 m2 (135,000 sq. ft.) Bangalore, India facility. Through a strategic collaboration with Boehringer Ingelheim, Kemwell is a single-source provider, supporting early product development to commercial supplies of biopharmaceutical products. Through this collaboration, Kemwell clients have access to Boehringer Ingelheim’s cell line, BI HEX® technology platform. Kemwell clients also have preferred access to large-scale commercial production via Boehringer Ingelheim facilities in Germany. With this cooperation, Kemwell Biopharma and Boehringer Ingelheim provides customers with state-of-the-art technology & know-how from Europe, with the benefit of low cost manufacturing from India.
Core Capabilities:
- Mammalian cell culture
- Process development up to 80L
- GMP manufacturing (400L and 2000L)
- Clinical Trial Material (CTM) manufacturing
- Aseptic fill & finish
- Analytical development and validation
- Stability studies
- Microbial fermentation (future)
The site supports cGMP drug substance manufacturing and sterile fill and finish, with a separate process development laboratory to support production of protein therapeutics from mammalian cell culture or microbial fermentation.