title: New guidance on codes of practice, standardized methods and regulations for cell-based therapeutics.
abstract: Consultations with members of the UK regenerative medicine community have identified the need for greater overall clarity regarding the current legislation, guidance and standards to be used. To facilitate this, the UK Department of Trade and Industry commissioned the British Standards Institution to develop guidance on the product pathway from cell/tissue donation to clinical trial for cell-based therapies within the UK and outline the accompanying legislation, codes of practice, guidance documents and standards for this process. This document will be aimed at a cross-section of end users from academic groups through to small and medium enterprises, larger industrial companies and the general public.
authors.affiliation: LGC Limited, Teddington, Middlesex, UK. neil.harris@lgc.co.uk
authors.forename: Neil
authors.initials: N
authors.lastname: Harris
authors.forename: Caroline
authors.initials: C
authors.lastname: Munro
authors.forename: Bhavisha
authors.initials: B
authors.lastname: Patel
mesh_terms: D017690:Cell Transplantation / Q000379:methods* / Q000592:standards*; D002986:Clinical Trials as Topic / Q000592:standards*; D006801:Humans; D017410:Practice Guidelines as Topic / Q000592:standards*; D014019:Tissue Donors; D006113:United Kingdom