We provide a dedicated home for:
- the development of Advanced Therapeutic Medicinal Products (ATMPs)
- regenerative medicine therapies for use in clinical trials
- tissue preparation for transplant
- the development of human Embryonic Stem Cells (hESCs)
The Facility has over 25 years' experience of working with hematopoietic stem cells and more recent experience with the GMP-compliant manufacture of ATMPs.
The Facility is run as a partnership between Newcastle University and the Newcastle upon Tyne Hospitals NHS Foundation Trust. The main GMP clean rooms are based at the International Centre for Life in central Newcastle, while the sister clean room facility is based in Haematological Sciences (Institute of Cellular Medicine) at the Royal Victoria Infirmary.
History of the Facility
The Facility's cleanrooms at the International Centre for Life were built in 2006 following significant investment from the Regional Development Agency (One North East), the Medical Research Council (MRC) and the Newcastle upon Tyne Hospitals NHS Foundation Trust. They were then commissioned for use from Spring 2007 as part of an integrated project with refurbishment of the laboratories of Newcastle Fertility Centre.
The Centre for Life cleanrooms were built by Laing O’Rourke as part of a ‘Procure 21’ programme. Specialist clean room design and build was sub-contracted to Thermal Transfer Ltd. A number of external consultants with experience of GMP and MHRA compliance were employed to make sure that the design of the build would comply with the strict regulations that would need to be upheld if the rooms were to become a useful resource for the University, the Trust and to the potential external companies contracted to use this multi-million pound investment.
In late 2009, the GMP cleanrooms at the Centre for Life were joined with the existing Haematological Sciences cleanrooms at the Royal Victoria Infirmary to form a single GMP compliant unit responsible for cellular manufacture in Newcastle - the Cellular Therapies Facility.