New guidance on codes of practice, standardized methods and regulations for cell-based therapeutics

Authors: Harris, Neil¹; Munro, Caroline; Patel, Bhavisha

Source: Regenerative Medicine, Volume 1, Number 5, September 2006 , pp. 705-707(3)

Publisher: Future Medicine

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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.

Keywords: cell-based therapeutics; guidance; process map; regulations; standards

Document Type: Research article

DOI: 10.2217/17460751.1.5.705

Affiliations: 1: 1LGC Limited, Queens Road, Teddington, Middlesex, TW11 0LY, UK., Email: neil.harris@lgc.co.uk

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