Newcastle bio-manufacturing facility
NESCI have a new clean room facility situated at the International Centre for LIFE, in central Newcastle. This facility has been designed, primarily to support the world class scientific research into Stem Cell therapies being conducted by NESCI scientists. A secondary, but equally important target is to provide a resource to the wider UK and European Stem Cell community (academic and industry).
The facility provides a centre for the preparation of clinical grade material for use in regulated clinical trials. To assist in this process the facility will operate to the standards of Good Manufacturing Practice (GMP); which is a formal regulated standard applied to the pharmaceutical and biopharmaceutical industries. Application of the GMP standards to the activities of NESCI scientists will also ensure compliance with other regulatory schemes that apply to the work carried out within the facility.
If you wish to find out more about our facility, and should you wish to explore the potential for partnership or commercial opportunities please see brochure and FAQ's attached
Facility Features
The facility has been built on a modular two suite basis to allow work to be carried out on somatic stem cells (eg cord blood) and human Embryonic Stem Cells without compromising the features of either.
The suites have been built to provide a GMP Grade B (ISO BS EN 14644 Grade 7) background environment; with cell manipulations carried out in GMP Grade A environments (ISO grade 5) provided by Class II Microbiological Safety Cabinets.
Each suite is supported by a dedicated 'Prep Lab' which are designed to operate at GMP Grade C, and provide an access route for materials to enter the appropriate GMP Grade B suite.
Some Fast Facility Facts:
GMP Grade B
- 9 suites (with 2 self contained corridors)
- 2 self contained Suites (Somatic (4 Labs))
- All Labs have CO2 supplied from the basement
- Static Pressure/Air Changes (per hour) - 55 Pa/35 (Grade B)
- Grade A Environment - Provided by Class II Microbiological Safety Cabinets
- Storage Facilities - Secure Cryostore, Suite specific -80, -20 & +2-8oC incubators
GMP Grade C
- 2 Self Contained Suites (Embryonic (5 labs))
- ES Suite has N2 gas supplied from the basement
- Static Pressure/Air Changes (per hour) - 35Pa/20 (Grade C)
- Grade A Environment - Continuously monitored for non-viable particulates
- Storage Facilities - Controlled quarantine/released goods
Facility Access
As is common in GMP facilities access is restricted to those individuals who have an operational requirement to use the facility; this is controlled by use of proximity cards.
The GMP Grade B facilities are entered via dedicated changing areas, where staff will put on suitable clean room clothing.
Facility Operation
The facility is operated by NESCI personnel, with a dedicated core group providing guidance and training to users on all aspects of GMP as they apply to the facility (eg gowning procedures) as well as ensuring that all processes carried out in the facility, it's environment and the fabric of the unit are maintained to the high standards of GMP.
If you wish to find out more about our facility, and should you wish to explore the potential for partnership or commercial opportunities please see brochure and FAQ's attached
