Kemwell Biopharma | Kemwell Biopharma Pvt Ltd

Kemwell Biopharma is a leading mammalian cell-based biologics Contract Development and Manufacturing Organization (CDMO) headquartered in Bengaluru, India. As a trusted partner to global biopharmaceutical companies, Kemwell provides end-to-end biologics development and manufacturing services—from cell line and process development to cGMP clinical and commercial manufacturing.

Kemwell’s 15,000 sq. m state-of-the-art facility, designed and developed in collaboration with Boehringer Ingelheim, offers world-class infrastructure and capabilities, including:

• Process Development & Characterization: Expertise in developing processes for complex biologics such as monoclonal antibodies (mAbs), bispecific and trispecific antibodies, and fusion proteins.
• Analytical Development: Development, qualification, and validation of in-process and release tests for biologics.
• Formulation Development: Development of liquid and lyophilized formulations, including high-concentration protein formulations, supported by stability studies to confirm the final formulation.
• Manufacturing Capabilities: Over 5,000 L mammalian cell culture capacity (both stainless steel and single-use bioreactors) for cGMP drug substance manufacturing, along with sterile fill-finish facilities for both vials and prefilled syringes (PFS) for drug product manufacturing.

In 2025, Kemwell successfully completed a U.S. FDA Pre-Approval Inspection (PAI) for an injectable drug product for the U.S. market, demonstrating compliance with global regulatory standards and reinforcing Kemwell’s commitment to quality and manufacturing excellence.

Established in 1980, Kemwell has a long-standing legacy of partnerships with global pharmaceutical leaders such as Bayer, GSK, Merck KGaA, Novartis, and Pfizer. After divesting its small-molecule business in 2016, Kemwell now focuses exclusively on mammalian cell-based biologics, leveraging deep technical expertise and operational excellence to deliver cost-effective, high-quality solutions from preclinical development through commercial manufacturing.