The UK’s emerging regulatory framework for point-of-care manufacture: insights from a workshop on advanced therapies

Published: 30 September 2021
Commentary
Edison Bicudo,
Edison Bicudo
Department of Science, Technology, Engineering, and Public Policy, University College London, Shropshire House (4th Floor), 11-20 Capper Street, London WC1E 6JA e.bicudo@ucl.ac.uk
Irina Brass,
Irina Brass
Department of Science, Technology, Engineering, and Public Policy, University College London, Shropshire House (4th Floor), 11-20 Capper Street, London WC1E 6JA
Penny Carmichael,
Penny Carmichael
Department of Science, Technology, Engineering, and Public Policy, University College London, Shropshire House (4th Floor), 11-20 Capper Street, London WC1E 6JA
Suzanne Farid
Suzanne Farid
Department of Science, Technology, Engineering, and Public Policy, University College London, Shropshire House (4th Floor), 11-20 Capper Street, London WC1E 6JA
Suzanne Farid is Professor of Bioprocess Systems Engineering at the Advanced Centre for Biochemical Engineering at University College London (UCL) and Deputy Head of Department (Education). She is Co-Director of the Future Targeted Healthcare Manufacturing Hub in collaboration with industrial and academic consortia to revolutionize the delivery of cost-effective stratified protein-based and personalized cell-based therapies to patients. She is also Director of the UCL-AstraZeneca Centre of Excellence. She leads research on ‘Decisional Tools’ to facilitate cost-effective bioprocess design, capacity planning, R&D portfolio management, root cause analysis and manufacturability assessments for biopharmaceuticals ranging from mAbs to cell and gene therapies. She sits on the ISCT Business Models and Investment Sub Committee, UK BioIndustry Association Manufacturing Advisory Committee and is a Fellow of the IChemE. She obtained her Bachelor’s and PhD degrees in Biochemical Engineering from UCL.

Point-of-care (POC) manufacture can be defined as the production of therapies in clinical settings or units close to hospitals and patients. This approach is becoming increasingly viable due to the emergence of flexible manufacturing technologies. Expecting an increase in this kind of production, the UK’s regulatory agency, the Medicines and Healthcare products Regulatory Agency (MHRA) is proposing a regulatory framework specifically designed for POC manufacture. To discuss the challenges of POC manufacture and the MHRA’s proposal, the EPSRC Future Targeted Healthcare Manufacturing Hub (FTHMH) organized a workshop drawing insights from specialists in cell and gene therapy manufacture. Through presentations and discussion roundtables, the workshop highlighted the challenges for the UK and other countries implementing POC manufacture. The workshop attendees stressed four main issues: quality control; standardization and equipment use; availability of qualified personnel; and the challenges to be met by hospitals participating in POC manufacture systems. This commentary provides a summary of the points discussed in this workshop.

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