Project: Chain of Custody/Chain of Identity

Type: Standards Advancement Project

Partners: ICCBBA and The SCB Cell Therapy, Gene Therapy, and Tissue Engineering Working Groups

Description:

Chain of custody (COC) and chain of identity (COI) are records used in the regenerative medicine therapy manufacturing process to ensure product safety and quality. COI is a record associated with a single patient, including health records both before and after treatment. COC records all points of transfer and control for a product, including product starting material and all in-process manipulations through the point of delivery.

COC and COI currently lack standardized definitions and strategies. Because of this, stakeholders throughout the regenerative medicine supply chain often use different tracking systems or formats, which can potentially result in inaccurate or incompatible records. Such errors create a risk of administering the wrong product to a patient or the inability to administer a product due to delays.

SCB is coordinating a working group to advance a standard for implementation of a COI identifier. Use of a standard system for identifying COI information for all starting material types could enable consistent and efficient tracking of cell therapy products derived from a specific patient throughout the collection, production, and delivery process.

Progress:

(learn more about the standards advancement process)

Assembled a Working Group: COC and COI are complex aspects of regenerative medicine product labeling that would benefit from their own set of requirements. The working group for the SCB-coordinated project to update the current ISBT 128 labeling standard identified a need for dedicated standards for COC and COI. In response, SCB assembled a separate working group to explore the potential for new standards for COC and COI.

Conducted a Feasibility Assessment: In December 2020, SCB organized a meeting of experts from multiple stakeholder groups to discuss barriers and opportunities for potential COC/COI standard topics. SCB developed a feasibility report detailing the outcome of the discussion and next steps for a standard.

Providing Coordination Support: SCB is coordinating the working group as it develops the draft standard. The standard is currently undergoing final voting.

Get Engaged:

SCB needs subject matter experts like you to join the working group. To help, please contact SCB.