Roslin Cells is Granted an MIA(IMP) and Manufacturer's 'Specials' Licence for Cellular Therapy Facility
Roslin Cells Ltd, announced today that its GMP Cellular Therapy Manufacturing Facility within the Scottish Centre for Regenerative Medicine has recently been licensed by the Medicines Healthcare Products Regulatory Agency (MHRA) for the manufacture of human cell therapy products. This followed a very successful inspection of the operation of the facility carried out by the MHRA's Medicines Inspectors. The company has 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 the company to manufacture and release ATMPs intended for specific patients.
Roslin Cells Ltd is a world leader in the development of cell therapies and pluripotent stem cells for applications in research, drug discovery and therapy. This achievement represents a major milestone in the development of Roslin Cells and the progression of the company to becoming the Contract Manufacturer of choice, for those wishing to manufacture cell-based therapies within Europe.
Janet Downie, Roslin Cells’ Chief Operating Officer, commented “Attaining these licences has been a key goal for the company and our dedicated team has worked tirelessly to set up and validate the facility. An essential element of a successful GMP operation is undoubtedly the effectiveness of the GMP team and their ability to achieve excellence. I am delighted to have reached this stage and look forward to welcoming new customers to our state of the art facility.”
About Roslin Cells
Roslin Cells was spun out of the world renowned Roslin Institute in 2006, through funding from Scottish Enterprise and now has 25 staff based at the Edinburgh BioQuarter.
The company operates development laboratories within Nine, Edinburgh BioQuarter and operates the state-of-the-art, seven clean room GMP Cellular Therapy manufacturing facility in partnership with the Scottish National Blood Transfusion Service (SNBTS) within the Scottish Centre for Regenerative Medicine (SCRM). This University of Edinburgh owned, high specification facility was specifically designed for the GMP manufacture of cell therapies and funded by Scottish Enterprise.
Roslin Cells currently has a number of products and services to offer customers, including; cell therapy manufacture, cell banking, human embryonic stem cell lines (clinical and research grade) and induced pluripotent stem cell production.
For more information or for more details of our products and services please contact:
Dr Jonny McMichael, New Business Manager, Tel. + 44 (0) 131 658 5189; Email:firstname.lastname@example.org, or
Janet Downie, Chief Operating Officer, Tel. + 44 (0) 131 658 5182; Email:email@example.com