The National Institute for Biological Standards and Control has partnered with The University of Sheffield and other scientific institutions across England and Wales to establish a new ‘Gene Therapy Innovation and Manufacturing Centre’ (GTIMC).
This centre, based in Sheffield, is one of three new facilities that will form a national network of ‘Gene Therapy Innovation Hubs’ funded by LifeArc, the Medical Research Council, and the Biological Sciences Research Council.
By providing access to clinical trial materials, translational advice and regulatory guidance, these hubs will facilitate academic-led trials to enable the development of the most novel genetic medicines.
The NIBSC will rely on its world-leading expertise in biological standardisation to advise on analytical methods related to the use of adeno-associated viral (AAV) vectors. Additionally, the institute will offer training in regulatory science and will help to support the standardisation of gene therapy products.
Dr Yuan Zhao, Principal Scientist in the Advanced Therapies Division at the NIBSC comments:
“We are excited to be working with The University of Sheffield as part of this new initiative. The Gene Therapy Innovation and Manufacturing Centre provides a welcome opportunity to identify the key challenges and knowledge gaps facing academic groups looking to run clinical trials. By offering increased access to essential regulatory and translational support, we can streamline the development of safe and effective therapies that have the potential to transform the lives of millions of individuals affected by genetic conditions.”
Further information on the Gene Therapy Innovation Hub network is available from the LifeArc website.