Newcastle Cellular Therapies Facility

GMP Manufacturing Campaigns

GMP Manufacturing Campaigns

The core service provided by the Facility is the bespoke manufacturing of cellular therapy and regenerative medicine products.

For details of our track record in manufacturing cellular products for clinical use, see our Expertise and Experience.

Services provided as part of a manufacturing campaign in the Facility include:

  • development of Investigational Medicinal Product Dossier (IMPD)
  • assistance in obtaining Clinical Trials Authorisation (CTA)
  • support in writing grant applications for GMP manufacturing
  • access to fully trained, qualified production staff
  • full technology transfer service for new projects, including incorporation of SOPs into quality management systems.
  • weekly contract cleaning
  • environmental monitoring
  • on-call alarm response (24/7)
  • liaison with the MHRA
  • monitoring and maintenance of key equipment, including the HVAC air handling unit
  • provision of a Qualified Person for product release