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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.

[02 July 2021]


Version 7.52.0 of the ISBT 128 Product Description Code Database is Now Available

Version 7.52.0 of the ISBT 128 Product Description Code Database is now available and can be downloaded from the Product Description Code Database page.

[02 July 2021]


Executive Director Advertisement

Redlands, CA - January 15, 2021: The Board of Directors of ICCBBA are seeking to appoint an Executive Director to take on the position on the retirement of the current post-holder.  The position is being advertised internationally and re-location to the USA is not required. It is anticipated that the successful candidate will be appointed in mid-2021.

Applicants must hold a minimum of a Masters degree, be fluent in English, and have a minimum of five years leadership experience, preferably in the non-profit healthcare field.

Knowledge of general trends in biotherapeutics and informatics, together with familiarity with ISBT 128 is desirable.

Experience of working internationally across a wide range of cultures would be an advantage.

Personality assessment may be required for qualifications. 

For any questions regarding the position please email: EDapplication@isbt128.org.

Applications, including a cover letter and resume to be submitted to EDapplication@isbt128.org, This position will remain open until filled.

For more information visit https://www.isbt128.org/careers

[Updated 24 June 2021]


Version 6.0.0 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 6.0.0: ST-001 ISBT 128 Standard Technical Specification – PDF (2 MB)

[28 December 2020]


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]


ICCBBA ANNOUNCES TRANSITION PLAN FOR EXECUTIVE DIRECTOR

CA - ICCBBA announces its plans to recruit an Executive Director, to replace Paul Ashford, who has indicated his intention to retire December 31, 2021.

In early 2021, the ICCBBA Board will be commencing an international search for an Executive Director who could join the organization from mid-year (to provide a six-month transition period.) Mr. Ashford has successfully led ICCBBA working primarily from his office based in the UK, and this has helped to strengthen the international credentials of the organization.

[14 Dec 2020]


Newly Released Technical Bulletin : TB-015 Bacterial testing strategies for Platelets - US Guidance v1.0.0 - PDF

TB-015 Bacterial testing strategies for Platelets - US Guidance v1.0.0 - PDF

The purpose of this interim guidance is to assist US based blood facilities in the selection of the correct labels for labeling platelets in the US based on the FDA Guidance: Bacterial Risk Control Strategies for Blood Collection Establishment and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion (September 2019). 

[05 Nov 2020]

 


New Product Description Codes for High and Low Titer Covid-19 Convalescent Plasma will be Available by Early November

ICCBBA is responding to the FDA COVID-19 Convalescent Plasma EUA Decision Memorandum by introducing new product description codes to indicate high and low titer CCP. In order to implement the codes in an efficient manner, two new product description codes, one for high titer and one for low titer, will be created for all current U.S. requested CCP codes (92).  These codes will be available by the early November release of the PDC database.  Any additional codes needed can be requested via the normal code request process. The alternative practice of using special testing codes with current CCP product codes to designate the titer status of the product may continue to be utilized.

[30 September 2020]


Version 3.23 of the GRID Issuing Organization Number Database is Now Available

The data files associated with the GRID Issuing Organization Number (ION) Database can be found here:

The specifications for the structure of the Global Registration Identifier for Donors (GRID) Issuing Organization Number (ION) and information on how to obtain and update an ION can now be found in the GRID Issuing Organization Number Database standards document (ST-015).

[05 Aug 2020]