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GMP gene therapy vector production

  • Document type:
    Publication
  • Author:
    Department of Health
  • Published date:
    9 February 2006
  • Primary audience:
    Professionals
  • Publication format:
    Electronic only
  • Gateway reference:
    Not required
  • Series number:
    A4
  • Pages:
    13
  • Copyright holder:
    Crown copyright

Report of a workshop hosted by the Department of Health on 15 December 2004.

The Clinical Trials Directive, which became part of UK law in May 2004, requires the manufacturing of all Investigational Medicinal Products (IMPs) to the standards of Good Manufacturing Practice (GMP). 

On 15th December 2004, DH held a workshop on GMP gene therapy vector production.  The workshop had three objectives:

  • Facilitate dialogue, coordination and collaboration between NHS initiatives to set up GMP facilities for gene therapy vector production,
  • Explore the possibility of setting up a consortium of vector production facilities,
  • Make recommendations to DH for the best way forward to support UK gene therapy.

Summary of recommendations

Recommendation 1:
Existing GTAC approved trials that are experiencing lack of money for vector production must have priority for funding.  This will ensure that patients will speedily receive experimental medicines that they may not otherwise obtain.

Recommendation 2:
A longer-term analysis should be undertaken assessing the likely demand for NHS vectors from 2010, and a strategy for how that demand might be best met, should be developed.

Recommendation 3:
 Coordination of those facilities based in academic, NHS and not for profit organisations is desirable.  A consortium approach should be supported, in order to encourage sharing of facilities and expertise.

Recommendation 4:
A translational strategy for gene therapy research in the NHS is needed if developments in this fast moving field are to be harnessed for future patient benefit. A more detailed analysis of gene therapy roadblocks should be undertaken and this should include issues arising from the implementation of the CTD.

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