Completed Materials & Manufacturing

Automatic Cell Processor for GMP Manufacture

In plain English

AI plain-English summary

A new automated cell processor will allow Oxford researchers to manufacture advanced cellular therapies for first-in-human clinical trials under strict regulatory standards. The University of Oxford currently lacks onsite Good Manufacturing Practice (GMP) capacity for producing cell-based treatments such as engineered T cells, gene-edited therapies, and expanded stem cells. Without this equipment, promising academic discoveries cannot be tested in patients because they cannot be manufactured to the safety and quality standards required for human trials. The CliniMACs Prodigy system fills that gap by automating the complex, sterile production of living cell therapies. If successful, the processor will enable early-phase clinical trials that de-risk new cellular technologies, increase the value of intellectual property, and strengthen links between academic research and the UK biopharmaceutical industry. The equipment is part of a wider £3 million university investment in dedicated clean room space at the Oxford Clinical Biomanufacturing Facility. The MRC is asked to part-fund the purchase, with Oxford providing 30% matching support. The immediate impact is on research infrastructure rather than on patients directly, but the ability to manufacture therapies for first-in-human trials is a necessary step before any new cell-based treatment can reach the clinic.

View original technical description
We are requesting MRC funding to part support the purchase of a CliniMACs Automated Cell Processor for the purpose of Good Manufacturing Practice (GMP)-compliant production of advanced cellular therapeutics for first-in-human academic trials. The University of Oxford will provide 30% matching funding if this application is successful. Acquisition of the equipment will enable University of Oxford researchers to enhance the impact of their research in the areas of ex vivo haematopoietic stem cell expansion, regulatory or anti-tumour T cell therapies, antigen receptor gene therapy and gene editing. Furthermore, the ability to perform early phase clinical trials will de-risk new cellular technologies as commercial entities and increase the value of IP, will have strong potential to promote new discovery by enhancing investigator opportunities for experimental medicine, and will foster wider engagement with the bio-pharmaceutical ecosystem in the UK. Acquisition of a Prodigy is part of a wider intent by the University to provide onsite GMP manufacturing capability through the Oxford Centre for Advanced Cellular Therapeutics (OxACT). This new endeavour is supported by £3 million investment which will be used to support capital costs for building dedicated clean room space for GMP manufacture of cell therapies in the Oxford Clinical Biomanufacturing Facility.

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Researchers

Adam Wilkinson (Co-Investigator)Ahmed Ahmed (Co-Investigator)Catherine Green (Co-Investigator)Fadi Issa (Co-Investigator)James Davies (Co-Investigator)Omer Dushek (Co-Investigator)Paresh Vyas (Co-Investigator)Persephone Borrow (Co-Investigator)Ronjon Chakraverty (Principal Investigator)

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Original classification

Research and Innovation

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