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drug substance

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


  • 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


Drug Substance cGMP Manufacturing



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