Jun 29 2004
Oxford University's Therapeutic Antibody Centre (TAC) has received a Manufacturer's Authorisation (Investigational Medicinal Products) from the Medicines and Healthcare Products Regulatory Agency (MHRA).
This authorisation allows the TAC to manufacture a range of monoclonal antibodies, recombinant proteins and vaccines for clinical trials in compliance with the Clinical Trials Directive which came into force in May 2004. The licence was awarded after the MHRA inspected the TAC in December 2002 and confirmed compliance with EU Good Manufacturing Practices (GMP).
Prof Geoff Hale, Research Director of the TAC, said: 'I am delighted that our team has achieved this recognition which we have been working towards for several years. The TAC has already manufactured more than 25 different monoclonal antibodies for clinical trials in a wide range of indications including transplantation, multiple sclerosis, leukaemia and diabetes.
'We have had the privilege of working with scores of clinical centres worldwide and several of our products have been licensed to the pharmaceutical industry for further development, including Campath® which is approved for the treatment of certain types of leukaemia.
'The new EU Clinical Trials Directive makes it much more difficult for non-commercial organisations to carry out clinical research. However, this Manufacturer’s Authorisation puts us in an excellent position to help both commercial and non-commercial organisations in development and clinical trials of new medicines.'
Professor Herman Waldmann FRS, Head of the Department and Professor of Pathology, said: 'This is an important achievement for the University and for UK research in Therapeutic Immunology. The award of the license recognizes the special role that the Therapeutic Antibody Centre has had, and will continue to have, in bringing new therapeutic antibodies to alleviation of human disease.'
Phase 3 trial assesses clazakizumab in kidney transplant recipients with caAMR