Regulatory requirements in the good manufacturing practice production of an epithelial cell graft for ocular surface reconstruction.
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.
['Sheth-Shah|Radhika|R|', 'Vernon|Amanda J|AJ|', 'Seetharaman|Shankar|S|', 'Neale|Michael H|MH|', 'Daniels|Julie T|JT|']
D064591:Allografts D018929:Cell Culture Techniques D004847:Epithelial Cells D005128:Eye Diseases D006801:Humans D033581:Stem Cell Transplantation D013234:Stem Cells D006113:United Kingdom
good manufacturing practice cell therapy quality control and cleanroom