Point-of-Care Manufacture: Regulatory Opportunities and Challenges for Advanced Biotherapeutics

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Point-of-Care Manufacture: Regulatory Opportunities and Challenges for Advanced Biotherapeutics

Bicudo, E; Carmichael, P; Brass, I; (2021) Point-of-Care Manufacture: Regulatory Opportunities and Challenges for Advanced Biotherapeutics. University College London (UCL): London, UK. Green open access

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Abstract

On 29 June 2021, UCL’s Future Targeted Healthcare Manufacturing Hub (FTHMH) held an online workshop to discuss the concepts and rationale of a new point-of-care (POC) manufacturing regulatory framework in development by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The proposal, which seeks to address the unique challenges of manufacturing healthcare products at, (or close to), the POC, is anticipated for publication and public consultation in summer 2021.

Type:	Report
Title:	Point-of-Care Manufacture: Regulatory Opportunities and Challenges for Advanced Biotherapeutics
Open access status:	An open access version is available from UCL Discovery
Publisher version:	https://www.ucl.ac.uk/steapp/collaborate/policy-im...
Language:	English
Additional information:	This version is the version of record. For information on re-use, please refer to the publisher’s terms and conditions.
UCL classification:	UCL UCL > Provost and Vice Provost Offices > UCL BEAMS UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science > STEaPP
URI:	https://discovery.ucl.ac.uk/id/eprint/10132742