Skip to main content

Drug Substance cGMP Manufacturing

As one of India’s largest and most preferred contract manufacturer of biopharmaceuticals, Kemwell operates multiple world-class GMP manufacturing facilities for the production of mammalian cell culture based biopharmaceuticals- 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

 

Drug Substance cGMP Manufacturing

About

We are professional and reliable provider since we offer customers the most powerful and beautiful themes. Besides, we always catch the latest technology and adapt to follow world’s new trends to deliver the best themes to the market.
Read More ->