GMP cell therapy
Integral to the CRM building and crucial to CRM's goal of translating our research into clinical applications is our state of the art 1000sq m good manufacturing practice (GMP) cellular therapy facility.
The facility was specifically designed in consultation with the Medicines and Healthcare Regulatory Agency (MHRA) to meet the evolving regulatory expectations for cell therapy manufacturing within the UK and Europe. The facility is comprised of 7 high quality clean rooms (4x Grade B, 2x Grade C and 1x Grade D) including support areas and dedicated GMP quality control laboratories for stem cell characterisation and safety testing.
In addition to all the equipment necessary for cell therapy processing, the key features of the facility include:
- Vapour phase Hydrogen Peroxide pass through hatches;
- Class II safety cabinets with integrated microscopes for primary tissue dissection;
- Liquid nitrogen free controlled rate freezers.
The facility is licenced by the Human Embryology Fertilisation Authority (HFEA), Human Tissue Authority (HTA) and MHRA and is jointly operated by RoslinCT and the Scottish National Blood transfusion Service (SNBTS).
For enquires regarding this facility please contact Janet Downie (RoslinCT) or Neil McGowan (SNBTS).