Cellular Therapies (GMP) Facility

Description

www.ncl.ac.uk/ctf

The Cellular Therapies Facility is a state-of-the-art clean room GMP service providing a dedicated home for the development of Advanced Therapeutic Medicinal Products (ATMPs), regenerative medicine therapies for use in clinical trials and tissue preparation for transplant.

It has over 15 years experience in the production of haematopoietic stem cells for transplantation and offers a Regional Transplant Service. The Facility also works with leading clinicians to develop and manufacture novel cellular therapies.

The facility consists of 9 EU GMP Grade B clean rooms, supported by 2 Grade C preparation rooms, making the provision one of the largest academic run units in Europe. Cell manipulations are carried out in Grade A environments provided for by Class II Microbiological Safety Cabinets, with integrated non-viable particle monitoring.

The Cellular Therapies Facility holds a Human Tissue Authority licence, an MHRA Manufacturer Specials (MS) Licence and an MHRA Manufacturer’s Authorisation for Investigational Medicinal Products (MIA IMP) Licence.

Newcastle University combined with The Newcastle upon Tyne Hospitals NHS Foundation Trust is a recognised UK centre for translational research, with substantial experience of cellular manufacture and setting up and delivering cell therapy clinical trials.