Drug-Substance-Manufacturing

As one of India’s largest and most preferred contract manufacturer of recombinant biopharmaceuticals, Kemwell provides competitive manufacturing services at its new state-of-the-art manufacturing facility.

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 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