title: Regulatory requirements in the good manufacturing practice production of an epithelial cell graft for ocular surface reconstruction.
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.
authors.affiliation: Cells for Sight, Transplantation & Research Programme, University College London Institute of Ophthalmology, London, UK.|Ocular Biology & Therapeutics Division, University College London Institute of Ophthalmology, London, UK.
authors.forename: Radhika
authors.initials: R
authors.lastname: Sheth-Shah
authors.affiliation: Cells for Sight, Transplantation & Research Programme, University College London Institute of Ophthalmology, London, UK.|Ocular Biology & Therapeutics Division, University College London Institute of Ophthalmology, London, UK.
authors.forename: Amanda J
authors.initials: AJ
authors.lastname: Vernon
authors.affiliation: Pharmanswers LTD, 13 Station Road, Fulbourn, Cambridge, CB21 5ER, UK.
authors.forename: Shankar
authors.initials: S
authors.lastname: Seetharaman
authors.affiliation: Cells for Sight, Transplantation & Research Programme, University College London Institute of Ophthalmology, London, UK.|Ocular Biology & Therapeutics Division, University College London Institute of Ophthalmology, London, UK.
authors.forename: Michael H
authors.initials: MH
authors.lastname: Neale
authors.affiliation: Cells for Sight, Transplantation & Research Programme, University College London Institute of Ophthalmology, London, UK.|Ocular Biology & Therapeutics Division, University College London Institute of Ophthalmology, London, UK.
authors.forename: Julie T
authors.initials: JT
authors.lastname: Daniels
mesh_terms: D064591:Allografts; D018929:Cell Culture Techniques / Q000379:methods* / Q000592:standards*; D004847:Epithelial Cells; D005128:Eye Diseases / Q000628:therapy; D006801:Humans; D033581:Stem Cell Transplantation / Q000331:legislation & jurisprudence / Q000379:methods / Q000592:standards; D013234:Stem Cells; D006113:United Kingdom
keywords: cell therapy; good manufacturing practice; quality control and cleanroom