The Cell Therapy Catapult, the organisation dedicated to the growth of the UK cell and gene therapy industry by bridging the gap between scientific research and commercialisation, today announces the availability of the Cell History File (CHF) template document. The Cell History File template has been developed in conjunction with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), the Human Tissue Authority (HTA) and other cell therapy developers and manufacturers from academia and industry.
The Cell History File initiative was a key recommendation from the UK Regenerative Medicine Expert Group (RMEG), an expert group organised through the UK Government’s Department of Health, in response to a report from the UK’s House of Lords regarding the development and delivery of regenerative medicines.
The CHF template document is available on the Cell Therapy Catapult website. The non-mandatory document has been designed for all organisations involved in the procurement, testing, processing, storage and distribution of human cells and tissues for human application and/or therapeutic use. These could be for either autologous or allogeneic use and could also include a cell-banking step.
The CHF has been designed to fulfil the role of a ‘cell passport’ that can accompany a tissue or cell derived product as it progresses through various processing stages. The CHF is flexible to suit the individual requirements of developers, but can provide a structure for key information to be collected and contained in a single source. This will include key traceability and manufacturing information required by EU Directives and HCT/P in the US. It has also been designed to be complementary to other EU regulatory documentation.
“As the cell therapy sector continues to grow in the UK and internationally, and increasing numbers of therapies enter the clinic, it is critical for all involved that information on cell history is able to be stored and presented in an easy to read and identifiable format,” said Keith Thompson, CEO, Cell Therapy Catapult. “Initiatives by the Cell Therapy Catapult like the CHF offer simple but crucial practical steps to alleviate development bottlenecks, state requirements to all concerned, and ultimately contribute to speeding up therapies to reach patients.”
About the Cell Therapy Catapult
The Cell Therapy Catapult was established in 2012 as an independent centre of excellence to advance the growth of the UK cell and gene therapy industry, by bridging the gap between scientific research and full-scale commercialisation. With more than 100 employees focusing on cell and gene therapy technologies, we work with our partners in academia and industry to ensure these life-changing therapies can be developed for use in health services throughout the world. We offer leading-edge capability, technology and innovation to enable companies to take products into clinical trials and provide clinical, process development, manufacturing, regulatory, health economics and market access expertise. We aim to make the UK the most compelling and logical choice for UK and international partners to develop and commercialise these advanced therapies. Regenerative medicine is one of the UK government’s eight great technologies that support UK science strengths and business capabilities. The Cell Therapy Catapult works with Innovate UK. For more information go to ct.catapult.org.uk or visit www.gov.uk/innovate-uk.
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