The Cellular Therapies Facility was designed and built to enable the production of stem cells and derived cellular products under Good Manufacturing Practice (GMP) conditions. The Facility provides high specification room space, equipment infrastructure and air-handling capabilities that when combined with the process management requirements of EU GMP, will ensure biologics are produced for safe use in human applications.
The facility has been built on a modular two-suite basis. The suites have been built to provide a GMP Grade B (ISO BS EN 14644 Grade 5) background environment; with cell manipulations carried out in GMP Grade A environments (ISO grade 5) provided by Class II Microbiological Safety Cabinets, with integrated non-viable particle monitoring.
Each suite is supported by a dedicated 'Prep Lab' which is designed to operate at GMP Grade C, (ISO BS EN 14644 Grade7) and provide an access route for materials to enter the appropriate GMP Grade B suite. There are a total of 9 GMP Grade B laboratories. There are dedicated staff access routes to each of the Grade B suites; with proximity reader controlled access to one of the suites.
In addition, there are facilities for cryo-preservation, office and write-up facilities and an in-process Quality Control Laboratory. We also have controlled storage facilities with both quarantine and release capacity.
Commercial or academic partners wishing to use the Cellular Therapies Facility are also able to access other scientific and clinical facilities provided by Newcastle University such as FACS, genotyping and proteomics, MRI, PET and the Clinical Research Facility. Full details of all facilities are available on the Newcastle Biomedicine Facilities and Equipment page.