The Cell Therapy Catapult, the organization dedicated to the growth of the UK cell and gene therapy industry by bridging the gap between scientific research and commercialization, has announced 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 organized 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 organizations 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.”