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Process Development

Production of cell and gene therapy materials requires the utilization of a living system for their manufacture.  Catalent’s Gene Therapy team has been developing scalable upstream and downstream manufacturing processes since 1990.  With expertise that spans a multitude of production processes, including stable and transient expression in mammalian cells and virally-transduced production in mammalian and insect cells, our technical teams are ready to optimize your therapeutic development.

The most critical part of your development program is our commitment to establishing commercial-ready processes early, in order to enable the most streamlined transition of your program from clinical to commercial manufacturing. With a high amount of gene therapy products in accelerated pathway status, timelines for development and manufacturing are also compressed, requiring quick expert decision making in the early development phases.  At Catalent, we are focused on speed, simplicity and reproducibility as we develop your custom program to give you an advantage going into the clinic.

Using state-of-the-art single-use systems for enhanced quality and safety together with our superior know-how across all viral systems and deep experience with a variety of clients allows us to create a hand in hand partnership throughout development for every customer.

Our CGMP Development Capabilities include:

  • 10 CGMP suites across 23,000 sq. ft.
  • US/EU compliant facility and quality systems
  • 200L, 400L, or 800L production capabilities for suspension
  • Up to 2x iCELLis® Bioreactors 500
  • 30x iCELLis® Nanos, benchtop operation
  • 12x Applikon and 18x mPATH™
  • Option for Client Dedicated Equipment

We employ robust supply-chain management for critical manufacturing materials with preferred supply agreements with multiple suppliers for single-use manufacturing components, such as iCELLis® Bioreactors, HYPERstacks® cell culture vessels, single-use bioreactor bags, PEI, benzonase, and more.

iCELLis and mPATH are trademarks of Pall Corporation.
HYPERstack is a trademark of Corning Incorporated.