Consortium Will Address
Cell Product Coding and Labeling

Improvements in coding and labeling of cellular therapy products is the objective of a newly created consortium of organizations that includes ASBMT and 10 other national and international cell therapy organizations.

Meeting for the first time in September in Athens, the Cellular Therapy Coding and Labeling Advisory Group will promote standardization of terminology and product naming.   Specifically, the Advisory Group will review existing labeling regulations, such as those of the FDA and the European Tissue and Cells Directive, and design product label templates that satisfy the regulatory requirements.   The Advisory Group will promote the adoption of the ISBT 128 standard in cellular therapy facilities around the world, and provide advice and support to facilities introducing the standard.   It also will be advising on the further development of the ISBT 128 standard to support new therapies. 

The ISBT 128 standard originated in 1994 and is being used in at least 28 countries on five continents.   It provides for a donation numbering system that has a globally unique identification for each cellular product, a bar coding system for transfer of the information on the product label, a standard layout for the product label and a standard reference for use in electronic communications. 

Other organizations participating in the Advisory Group are:

• AABB
• European Group on Blood and Marrow Transplantation
• Foundation for the Accreditation of Cellular Therapy
• International Council for Commonality in Blood Banking Automation, Inc.
• International Society of Blood Transfusion
• International Society for Cellular Therapy
• ISCT Europe
• JACIE (Joint Accreditation Committee ISCT-EBMT) 
• National Marrow Donor Program
• World Marrow Donor Association

The charter for the Advisory Group is posted online.