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The Cell History File is designed as a “cell passport” for developers and manufacturers of tissue- and cell-based medicinal products.
The Cell Therapy Catapult, an organization involved in bridging the gap between scientific research and commercialization of cell and gene therapies in the United Kingdom, announced that the Cell History File (CHF) template document is now available.
The CHF 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.
This initiative was recommended by the UK Regenerative Medicine Expert Group (RMEG), 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 nonâmandatory 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.
The CHF has been designed to serve as 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, such as 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.
Source: Cell Therapy Catapult