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, fusion proteins and biosimilars
Analytical Development: Development, qualification and validation of in-process and release tests for biologics.
Formulation Development: Development of liquid and lyophilized formulations, and high-concentration protein formulations. Performing stability studies to confirm the final formulation.
Manufacturing Capabilities: Over 5,000 L mammalian cell culture capacity for cGMP drug-substance manufacturing, along with sterile fill-finish facilities for both vials and prefilled syringes (PFS) for drug-product manufacturing.
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Expertise
CDMO End to End Services for Mammalian Cell Based Biologics
Kemwell Biopharma works with a diverse portfolio of global biotech and pharmaceutical companies, ranging from emerging and mid-size biotechs to established multinational organizations who are seeking CDMO services