Passport Traces Cell Development History

A document that will effectively act a ‘cell passport’ for developers and manufacturers of tissue and cell based medicinal products has been announced by 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.

The Cell History File (CHF) template, 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, was a key recommendation from the UK Regenerative Medicine Expert Group (RMEG).

The non?mandatory document, now available on the Cell Therapy catapult’s website 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. 

Including key traceability and manufacturing information required by EU Directives and HCT/P in the US, it also complements 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.”