The NHS Blood and Transplant (NHSBT) Advanced Therapy Unit in Liverpool has been granted a Manufacturers' Authorisation for the production of cell and tissue-based Investigational Medicinal Products (IMP) for clinical trials. This authorisation, granted by the Medicines and Healthcare products Regulatory Authority (MHRA), opens the way for NHSBT to work with the regenerative medicine industry to take innovative cell and tissue therapies to the clinic. NHSBT's specialist production facilities include 32 clean rooms, staffed by trained and experienced scientists.
Keith Smith, lead quality specialist with NHSBT, said: "This authorisation confirms that our practices and quality system meet the stringent requirements of current Good Manufacturing Practice for the manufacture and supply of cell-based medicinal products. This complements NHSBT's existing authorisations for gene therapy medicinal products manufacture".
Professor John Kearney, NHSBT head of tissue services, said: "Regenerative medicine research is moving rapidly to develop therapies that will regenerate, repair or replace damaged tissues or cells. NHSBT offers high-quality translational development and production solutions to evolving regenerative medicine companies."
www.nhsbt.nhs.uk