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The Registered Facilities Database Has Been Updated

The Registered Facilities Database has been updated and is now available to licensed facilities. The database contains the names and locations of all ICCBBA-registered facilities worldwide and their assigned Facility Identification Numbers (FINs). It is available both as an Excel file (Registered Facilities.xlsx) and as a tab-delimited text file (Registered Facilities.txt).

Both files are available in the password-protected area of the website. Amendments to entries in these tables should be notified to the ICCBBA office.

For US facilities registered and/or licensed with the FDA, the name and location of your facility—as it appears in the Registered Facilities Database—should match what appears on your FDA registration and/or license.

[05 Jan 2022]


Version 7.57.0 of the ISBT 128 Product Description Code Database is Now Available

Version 7.56.1 of the ISBT 128 Product Description Code Database is now available and can be downloaded from the Product Description Code Database page.

ICCBBA is currently in the process of transitioning to a new website.The Database and Product Lookup Tools have now been redirected to the new website.

To receive access to the password-protected areas of the new website, users must have a new website account. If you do not have an account, please use this link for instructions on how to register for a password account on our website. https://www.isbt128.org/website-registration.

Below are some helpful links on the new website to help you access ISBT 128 Product Codes:

Database 

Product Lookup Program

Product Requests

[04 Januray 2022]


Version 6.1.0 of the Technical Specification is available now.

This document is a comprehensive description of the rules surrounding the use of ISBT 128 as well as guidance in the interpretation of these rules. 

Version 6.1.0: ST-001 ISBT 128 Standard Technical Specification – PDF (2 MB)

*ICCBBA is currently in the process of transitioning to a new website.The ISBT 128 Standard Technical Specification and other webpages/documents have now been redirected to the new website.

[20 December 2021]


A new Standard, Labeling of Collection Products for Cellular Therapy Manufacturing, has now been published

ST-018 - ISBT 128 Standard Labeling of Collection Products for Cellular Therapy Manufacturing 

The new standard was designed to address inconsistencies in labeling apheresis collection products that are being used in cellular therapy manufacturing and was developed in collaboration with industry partners including bluebird bio, GlaxoSmithKline, Gilead Sciences, Johnson & Johnson, Juno Therapeutics, Kite Pharma, Legend Biotech, National Marrow Donor Program (NMDP/Be The Match), Deloitte, AABB, FACT, Standards Coordinating Body for Regenerative Medicine, TrakCel, Vineti, and subject matter experts in apheresis nursing and quality assurance. The standard aims to reduce the risk of misinterpretation of patient data while providing consistency in labeling requirements to collection centers.

This builds on the existing ISBT 128 standards for cellular therapy and is a supplement to the ISBT 128 Standard Technical Specification (ST-001). Essential ISBT 128 traceability information is retained, while also accommodating sponsor/manufacturer information in a standardized manner. It defines the labeling requirements for cellular therapy apheresis collection products for further manufacturing into clinical trials products or approved products. It is for use only in situations where the sponsor/manufacturer has adopted this standard and has provided the necessary information to populate the sponsor/manufacturer section of the label. While designed for apheresis collection products, the use of the label on collection products for further processing from other sources is not prohibited. Future versions of this standard may be extended to cover other sources of collection products.

Comments and questions about the new Standard should be directed to iccbba@iccbba.org.

[17 December 2020]