Oxford University's Therapeutic Antibody Centre receives Manufacturer's Authorisation

Main Category: Public Health
Article Date: 29 Jun 2004 - 15:00 PDT

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Oxford University's Therapeutic Antibody Centre (TAC) has received a Manufacturer's Authorisation (Investigational Medicinal Products) from the Medicines and Healthcare Products Regulatory Agency, UK (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.'

For more information please contact the Press Office on (UK) 01865 280528.

Notes to editors:

The EU Clinical Trials Directive was implemented in the UK on 1 May 2004. It requires organisations which are manufacturing medicines for clinical trials to be authorised by the MHRA. Further information on the new regulations is available on the MHRA website http://www.mhra.gov.uk.

Campath® is a trademark of ILEX Pharmaceuticals LP and is marketed in Europe by Schering AG under the tradename MabCampath®. Further information is available from the website http://www.campath.com or from the company websites http://www.ilexoncology.com and http://www.schering.de.

The Therapeutic Antibody Centre was founded in Cambridge by Geoff Hale and Herman Waldmann in 1990 and moved to Oxford University in 1995. It has worked with a wide range of commercial, government and charity sponsors to develop new antibody-based treatments.

Besides manufacturing antibodies, the TAC also developed and validated analytical tests for the monitoring of clinical trials. In 2002 this service was spun-out of the University to form the company BioAnaLab Ltd (http://www.bioanalab.com). The original purpose-built 5000sq ft facility remains dedicated to the manufacture and testing of biological products.

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Press release issued by the University of Oxford.