The accreditors of this session require that you periodically check in to verify that you are still attentive.
Please click the button below to indicate that you are.
There are circumstances in collecting and processing cellular therapy products for further manufacture where more than one donation may need to be collected to deliver a given therapy. A new ISBT 128 Standard for the Chain of Identity (CoI) Identifier, developed based on requirements developed collaboratively with the Standards Coordinating Body, was published in December 2022. This new ISBT 128 data structure provides a standardized, globally unique identifier that can be used to link these donations together. This session will describe the hybrid (split) label format for labeling collection products for cell therapy manufacturing, the structure of the ISBT 128 Chain of Identity Identifier, the maintenance of the chain of custody, and how to become a CoI Identifier issuer. The session will also leverage experience from a cell therapy manufacturer’s journey to establish a chain of identity identifier and overcome bottlenecks in implementing strategies to maintain the chain of custody. An interactive discussion will delve into establishing an agreement between the entities involved in the collection for a given therapy regarding the scope of the therapy to be associated with a CoI Identifier and defining who is responsible for allocating the CoI Identifier that will be used throughout the lifecycle of the biological material, and when the CoI Identifier will be allocated.
Learning Objectives:
Differentiate between the ISBT 128 Donation Identification Number and the ISBT 128 Chain of Identity Identifier
Formulate an implementation strategy for the ISBT 128 split label designed for collection products for cellular therapy manufacturing
Describe the process of becoming an ISBT 128 Chain of Identity Identifier issuer
Assess which tools can be utilized by smaller companies with limited resources to manage standard requirements
Apply experiences from a manufacturer's journey to establish a Chain of Identity identifier
Moderator(s):
Zbigniew
Szczepiorkowski,
MD, PhD, FCAP,
Professor of pathology and laboratory medicine/director of Cellular Therapy Center,
Geisel School of Medicine at Dartmouth/Dartmouth-Hitchcock Medical Center