Biopharmaceuticals

Biopharmaceuticals

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 will have access to Boehringer Ingelheim’s 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 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.

R&D Process Development Services
  • Small-scale production for quality assessment
  • Material supply for toxicology studies
  • Cell banking
  • Upstream (cell culture) process development & optimization
  • Downstream (protein purification) process development and optimization
  • Assay development and validation
  • Stability studies
cGMP Manufacturing Services
  • Master and Working Cell Bank Preparation
  • Scale-up and process characterization
  • cGMP drug substance manufacturing
  • QC testing & release
  • Stability testing
  • Fill & finish (liquid and lyophilized vials & pre-filled syringes)