cGMP Manufacturing

cGMP Manufacturing

Kemwell offers full service contract Biopharmaceutical manufacturing, process development, formulation, & fill-finish capabilities at our newest 15,000 m2 (135,000 sf) Bangalore, India facility. Through collaboration with Boehringer Ingelheim, Kemwell is a single-source provider, supporting early product development to commercial supplies of biopharmaceutical products.

Core Capabilities:
  • Mammalian cell culture
  • Microbial fermentation (future plans)
  • Manufacture (80L – 2000L)
  • Process development
  • Pilot scale manufacturing
  • Fill & finish
  • Analytical development
  • Stability studies
cGMP Manufacturing Services
  • Master and Working Cell Bank preparation
  • Scale-up
  • cGMP Upstream manufacturing
  • cGMP Downstream manufacturing
  • QC testing & release
  • Stability testing
  • Cell line and product characterization
  • Fill & finish (vials & pre-filled syringes)

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.

Through this collaboration, Kemwell clients will have access to Boehringer Ingelheims’ cell line, BI HEX® technology platform. Kemwell clients will also have preferred access to large-scale commercial production via Boehringer Ingelheim facilities in Germany. With this cooperation, Kemwell Biopharma and Boehringer Ingelheim will provide the customer with state-of-the-art technology & know-how, with the benefit of low cost manufacturing from India.