Licences granted for manufacture of human cell therapy products
13 August 2013
Roslin Cells Ltd, the Scottish National Blood Transfusion Service (SNBTS) and the University of Edinburgh announced today that the GMP Cellular Therapy Manufacturing facility within the Scottish Centre for Regenerative Medicine (SCRM) has recently been licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) for the manufacture of human cell therapy products.
This Manufacturing facility at SCRM, part of the Edinburgh BioQuarter site, is central to the development of cellular therapies within Scotland and is now uniquely positioned to manufacture a number of cell therapies for clinical trials and help realise the Scottish Government’s ambitions for regenerative medicine and cell therapies.
Roslin Cells Ltd and SNBTS jointly operate this high specification facility and have been awarded a Manufacturer's Authorisation for Investigational Medicinal Products (MIA(IMP) which permits the manufacture and release of Advanced Therapy Medicinal Products (ATMPs) for use in clinical trials. In addition, a Manufacturer's "Specials" licence has been awarded which authorises both organisations to manufacture and release ATMPs intended for specific patients.
Janet Downie, Roslin Cells’ Chief Operating Officer, commented:
“Attaining these licences has been a key goal for the Scottish Centre for Regenerative Medicine and we are delighted to have reached this important milestone. Within Scotland we now have a key asset and also a talented multidisciplinary team capable of delivering cell therapies for patients and developing the cell therapy economy in Scotland.”
Alex Neil, Cabinet Secretary for Health said:
”Scotland has a world class reputation in regenerative medicine and stem cell research. The completion of this state of the art facility will further advance our understanding of the debilitating diseases this field seeks to address and their potential therapies. This will allow for both the health and wealth benefits to be realised in Scotland, supporting the life sciences sector in its growth aspirations”.
Prof Charles ffrench-Constant, Director of the MRC Centre for Regenerative Medicine also housed at the University of Edinburgh’s Scottish Centre for Regenerative Medicine, added:
“This achievement in creating Europe’s leading GMP Cellular Therapy Manufacturing Facility will provide scientists at the MRC Centre for Regenerative Medicine and beyond with tremendous opportunities. Meeting the requirements as set by the MHRA means the Facility can now start producing cells that are safe to use for clinical trials. This is an essential next step in the process of translating basic scientific discoveries into working therapies and I’m delighted we can now work towards developing and delivering novel cell-based therapies for degenerative disease.”