Manufacturing innovation

Access unique adaptive GMP cleanrooms designed to support the development and large-scale production of your autologous cell, allogeneic cell, or viral vector manufacturing processes.

Collaborate with us to accelerate your advanced therapy manufacturing and supply chain needs, ensuring they are robust and efficient, whilst meeting all regulatory requirements.

Technology transfer and GMP manufacturing

Working in collaboration with you, our expert team will help adapt and transfer your processes for Good Manufacturing Practice (GMP) manufacturing. Our capabilities in technology transfer and GMP production enable you to rapidly set up and develop your ATMP manufacturing process whilst benefitting from our expertise and infrastructure, reducing your risk and time to market.

Benefit from our expertise in:

  • Robust manufacturing strategy development
  • Process development where you retain your intellectual property; the people, process, quality management system, batch release, and IP all belong to the collaborator.
  • Technology transfer and process scale-up
  • MHRA licensing structures to ensure you can produce material for clinical or commercial use
  • Flexible, modular manufacturing approaches that enable you to adjust your manufacturing strategy as you grow from clinical to commercial manufacturing

Chemistry, manufacturing & control (CMC)

Chemistry, manufacturing and control (CMC) compliance ensures consistent quality for production of ATMPs.

Developing a CMC regulatory strategy involves robust quality assurance and quality control to ensure that final product is safe and efficacious for use. We can support you with all these elements, ensuring your processes will deliver a product that complies with regulations and is ready to scale.

Benefit from:

  • Access to the latest analytical procedures for ATMPs
  • Leading knowledge in the regulations for ATMP production
  • Environment monitoring to ensure the right conditions are maintained for your production process

Supply chain

We have worked closely with industry and therapy developers to establish solutions that optimise the supply chain for manufacturing of ATMPs.

Benefit from an established ATMP manufacturing ecosystem with:

  • Logistics and cryogenic shipping services through Cryoport's Global Supply Chain Hub
  • Local cryogenic storage at our Stevenage Manufacturing Innovation Centre (MIC)
  • Sterile kitting of GMP materials and reagents to maximise production
  • A robust supply chain utilised by our Stevenage and Braintree MICs

News feed

MHRA introduces regulations that allow decentralised manufacturing of therapiesMHRA introduces regulations that allow decentralised manufacturing of therapiesCell and Gene Therapy Catapult appoints Dr Ed Samuel as Chief Operating OfficerCell and Gene Therapy Catapult appoints Dr Ed Samuel as Chief Operating OfficerCellular Origins, Cell and Gene Therapy Catapult and Resolution Therapeutics form consortium to deliver fully automated robotics CGT manufacturing platformCellular Origins, Cell and Gene Therapy Catapult and Resolution Therapeutics form consortium to deliver fully automated robotics CGT manufacturing platformScience Minister Lord Vallance opens Digital and Automation Testbeds that will improve advanced therapies manufacturingScience Minister Lord Vallance opens Digital and Automation Testbeds that will improve advanced therapies manufacturing

Working on a cell or gene therapy innovation challenge?

Contact us today to find out how we can support you.