Technical Report

Bone Marrow Transplantation (2007) 40, 1085–1090; doi:10.1038/sj.bmt.1705859; published online 1 October 2007

Terminology and labeling of cellular products–2: Implementation plan

P Ashford1, P Distler1, A Gee1, A Lankester1, S Larsson1, I Feller1, K Loper1, D Pamphilon1, L Poston1, F Rabe1, I Slaper-Cortenbach1, Z Szczepiorkowski1 and P Warkentin1

1International Cellular Therapy Coding and Labelling Advisory Group

Correspondence: P Ashford, ICCBBA Inc., 1615 Orange Tree Lane, Ste 200, Redlands, CA 92374, USA. E-mail: paul.ashford@iccbba.org

Received 16 May 2007; Accepted 2 July 2007; Published online 1 October 2007.

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Abstract

The publication of new standards for terminology and labeling marks an important step in ensuring consistency and traceability of cellular therapies at the global level. However, it is only with the widespread implementation of the standard that the benefits can be truly realized. This paper provides guidance on the practical aspects of adopting these new standards for organizations with differing current levels of computerization. It discusses project management, equipment, licensing, and validation topics.

Keywords:

implementation, cellular therapy products, ISBT 128

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