The recently launched Newcastle Bio-manufacturing facility (BMF) is marketed by Cels and managed by the North East England Stem Cell Institute (NESCI). It was designed and built to enable the production of stem cells to a clinical standard and is housed within the prestigious International Centre for Life (ICFL) in the heart of Newcastle upon Tyne. The facility provides the room space and air handling capabilities that, when combined with the process management requirements of cGMP (current Good Manufacturing Practice), will enable the production of biologics for use in human patients.

The facility is operated by NESCI personnel, with a dedicated core group comprising a Quality Assurance & Facility Manager, a dedicated GMP Microbiology Technician and a GMP Cell Culture Scientist. These staff members are available to provide guidance and training to users on all aspects of GMP as they apply to the facility, as well as ensuring that all processes carried out in the facility, its environment and the fabric of the unit are maintained to the high standards of GMP. Additionally they provide basic environmental testing and monitoring support to the client if required and provide a scientist resource for the culture of cell lines.

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 is designed to operate at GMP Grade C, and provide an access route for materials to enter the appropriate GMP Grade B suite.

The Newcastle Bio-manufacturing Facility provides an excellent opportunity to build partnerships with internationally recognised stem cell scientists and clinicians working under the auspices of NESCI (North East England Stem Cell Institute). In addition it can offer a strategic route through which clients can establish a UK/European base for the production
of biologics to EU cGMP standard and to access new markets.

For further information, email Kenny Lang, Chief Innovation Officer, Cels