Biopharmaceuticals
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 (coming in 2012)
- Manufacture (80L – 2000L)
- Process Development
- Clinical Trial Material (CTM) Manufacture
- Pilot Scale Manufacturing
- Fill & Finish
- Analytical Development
- Stability studies
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.
R&D Process Development Services
- Small-scale production for quality assessment
- Expression plasmid expression / purification
- Mammalian cell transfection and clonal selection
- Cell line cloning
- Cell banking
- Upstream (cell culture) process development & optimization
- Downstream (protein purification) process development
- Assay development
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)