April 22, 2022

New FDA guidance: cell therapies and patient identifiers

When the US Food and Drug Administration (FDA) recently made two draft guidance documents for the cell and gene therapies available for comment, the Vineti team was quick to scan for one three-letter phrase that is core to our mission – COI.

COI stands for Chain of Identify, and it’s a foundational aspect of patient safety in advanced therapies. COI refers to the permanent, transparent association of a patient and/or donor’s unique identifiers to their tissue and/or cells from order through collection, manufacturing, administration, and post-treatment monitoring. Pairing COI with Chain of Custody (COC) — or the permanent data capture of tracking and handling information for a therapy at every step — provides a truly traceable, trustworthy process for patients and their clinicians providing care during advanced therapy treatments. 

In its recent draft guidance on CAR-T cell therapy products, the FDA included recommendations on COI, in-process drug product labeling, and the unique patient identifiers that make COI possible. This is an important recommendation for the entire cell and gene therapy (CGT) sector – and for patient safety. It’s also essential to our work here at Vineti, where we focus on developing digital technology that enables safe, efficient patient and product journeys for CAR-T cell therapies and other personalized therapeutics. 

Because CAR-T cell therapies are personalized treatments that are highly specific to a patient and require complex processes to produce, the risk profile to manufacture these products (as with any cell therapy) is higher and presents the need for measures that ensure the right therapy is administered to the right patient. The use of unique identifiers is one way to ensure that materials that are handled throughout the treatment workflow maintain COI and COC. 

Specifically, the guidance calls for at least two unique identifiers to establish and maintain COI on in-process cell therapy drug product labels. The guidance also suggests two separate patient/label checks before any cell therapy treatment is given, as follows: 

“To maintain the Chain of Identity (COI), labeling and tracking of material, from collection all the way through CAR T cell administration, must be documented (21 CFR Part 1271 Subpart D). Additionally, we recommend labeling include at least two unique identifiers with label checks built into the batch record prior to each processing step. The COI should also be maintained at the clinical site with two independent patient and label checks at bedside.”

Cell therapies are complex treatments, with a wide range of unique identifiers to choose from. Aside from site-specific patient identifiers, examples of other unique identifiers in cell therapy include those that specifically identify the source of the cellular material, such as those used in the existing Donor Identification Number (DIN) or Single European Code (SEC) systems. 

The complexity, distribution, and variation of the processes involved in delivering an advanced treatment also present the need to uniquely identify a cell therapy with the intended therapy recipient, especially for therapies derived from donor cells (allogeneic) and not the patient’s own cells (autologous). A specific COI identifier can satisfy this need. Based on extensive experience with CGT supply chains, Vineti believes that the advanced therapies industry needs an updated standard for COI ID, and we’ve presented a COI ID proposal to groups working on new industry standards.

Vineti’s COI approach addresses the FDA latest draft guidance by providing a solution that is configurable and can flexibly adapt to regulatory changes and the emergence of new personalized therapeutic approaches. Additionally, our COI ID approach provides a structure that also enables drug product uniqueness within a sponsor’s domain, as well as within the hospital setting.

Through our extensive work with more than 20 cell and gene therapy manufacturers in recent years, we’re always gathering insights into the direction of advanced therapies. We’ll also continue to monitor the latest regulatory guidance, and keep developing solutions that make compliance simpler for CGT innovators, clinicians, and the patients they serve.

Amy Fonte is a Product Management leader at Vineti. You can learn more about Vineti and how our cloud-based enterprise platform supports cell and gene therapy supply chains here. If you have feedback on our COI ID proposal, please contact us.