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Regulatory requirements in the good manufacturing practice production of an epithelial cell graft for ocular surface reconstruction

Sheth-Shah, R; Vernon, AJ; Seetharaman, S; Neale, MH; Daniels, JT; (2016) Regulatory requirements in the good manufacturing practice production of an epithelial cell graft for ocular surface reconstruction. Regenerative Medicine , 11 (3) pp. 307-320. 10.2217/rme-2015-0020. Green open access

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Abstract

In the past decade, stem cell therapy has been increasingly employed for the treatment of various diseases. Subsequently, there has been a great interest in the manufacture of stem cells under good manufacturing practice, which is required by law for their use in humans. The cells for sight Stem Cell Therapy Research Unit, based at UCL Institute of Ophthalmology, delivers somatic cell-based and tissue-engineered therapies to patients suffering from blinding eye diseases at Moorfields Eye Hospital (London, UK). The following article is based on our experience in the conception, design, construction, validation and manufacturing within a good manufacturing practice manufacturing facility based in the UK. As such the regulations can be extrapolated to the 28 members stated within the EU. However, the principles may have a broad relevance outside the EU.

Type: Article
Title: Regulatory requirements in the good manufacturing practice production of an epithelial cell graft for ocular surface reconstruction
Location: England
Open access status: An open access version is available from UCL Discovery
DOI: 10.2217/rme-2015-0020
Publisher version: http://dx.doi.org/10.2217/rme-2015-0020
Language: English
Additional information: Copyright © 2016 Future Medicine Ltd.
Keywords: cell therapy, good manufacturing practice, quality control and cleanroom
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > Institute of Ophthalmology
URI: https://discovery.ucl.ac.uk/id/eprint/1478655
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