A new analysis and commentary from industry stakeholders argues that variability across apheresis collection sites can directly affect cell therapy starting material quality, complicating comparability assessments when manufacturers change processes or scale capacity. The authors note that standardization should focus on elements tied to comparability and traceability, including minimum donor eligibility data, definitions of quality attributes, and product identification and labeling—while allowing flexibility where biology and clinical logistics require it. The piece points to existing standards such as ISBT 128 as a starting framework and calls for regulator recognition of best-practice standards developed through stakeholder consensus rather than starting from scratch.
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