Differences in apheresis collection and handling practices can affect the quality of materials used to make cell therapies, according to a recent analysis by Christina Celluzzi of the Association for the Advancement of Blood & Biotherapies and colleagues. The authors say targeted standardization could help developers manage this variability and produce more consistent therapies.
Cell quality is also shaped by biological factors, including a donor’s age, disease status, treatment regimen and donation history. But collection-site practices contribute to variation too, Celluzzi said. Differences at the apheresis stage can make it harder for manufacturers to compare processes when they transfer technology, change manufacturing methods or expand capacity.
The authors do not recommend standardizing every aspect of collection. Device choice and vascular access techniques, for example, may need to remain flexible. They argue that tighter alignment would be most useful for practices that support comparability and traceability, including minimum donor eligibility information, definitions of quality attributes, and product identification and labeling.
Celluzzi pointed to ISBT 128, a standard covering terminology, labeling and chain of identity, as a possible foundation for industry efforts. She said implementation support would be important so that standardization does not widen gaps in capability between collection sites. The authors also favor best practices developed by stakeholders through consensus efforts, with regulators recognizing or incorporating those standards.
The analysis also calls for clearer regulatory guidance on cell therapy starting materials. Celluzzi said the FDA could clarify how it distinguishes investigational from commercial materials, its expectations for collections outside the United States, and how consensus standards can support regulatory submissions.
More consistent procedures for receiving materials at manufacturing facilities could also help, including defined temperature limits and cryopreservation media specifications. Celluzzi additionally identified shared templates for leukapheresis manuals, standard operating procedures, and chain-of-custody and chain-of-identity records as useful measures. Risk-based site qualification could help manufacturers focus audits on product-specific risks rather than repeatedly reassessing established quality systems.