As one of India’s largest and most preferred contract manufacturer of biologics, Kemwell operates multiple world-class GMP manufacturing facilities for the production of mammalian cell culture based biologics- monoclonal antibodies, fusion proteins, etc. Over 4000L of bioreactor capacity is available for both clinical trials and commercial drug substance supply.
Core Competencies
- Mammalian cell culture
- Product types – monoclonal antibodies and other cell culture based recombinant proteins
- Clinical and commercial manufacturing
- GMP cell banking
- Integrated with process development and drug product manufacturing capabilities
- Comprehensive analytical support
Capabilities
- Upstream – Bioreactor train of 80L, 400L and 2 x 2000L stainless steel bioreactors
- Harvest – Continuous centrifugation and/ or lenticular filtration
- Downstream – Multiple chromatography and TFF steps; pre-and post-viral segregation – call to action
- Hybrid design – Stainless steel and single-use equipment
- Flexible and adaptable to different process requirements
- Designed for purifying high titer cultures
- State-of-the-art equipment with CIP, SIP capability
- Central data management system with 21 CFR part 11 compliance
- Process validation
- Cleaning validation
