Standardized Apheresis Processes Would Help Cell Therapy Sector
Variation in collection practices, or apheresis, and handling procedures is a source of cell therapy starting material variability and a major headache for manufacturers, suggesting a degree of standardization would help the industry. The post Standardized Apheresis Processes Would Help Cell Therapy Sector appeared first on GEN - Genetic Engineering and Biotechnology News .
Variability in cell collection practices at sampling sites affects the quality of starting materials for cell therapies, according to new analysis. Christina Celluzzi, PhD, from the Association for the Advancement of Blood & Biotherapies, emphasizes that apheresis stage variability complicates comparability assessments when manufacturers alter processes, transfer technology, or increase capacity, and hinders sponsors' ability to utilize comparability protocols and post-approval change strategies.
Standardization could assist cell and gene therapy developers, with some areas requiring greater standardization than others, such as minimum donor eligibility data elements, quality attributes definitions, and product identification and labeling. Existing standards, like ISBT 128, serve as a foundation for industry standardization efforts, paired with implementation support to prevent widening capability gaps between collection sites.
Collaboration among stakeholders, such as through consensus efforts led by organizations like PDA and ASTCT, would help develop technical best practices, with regulators recognizing or incorporating those standards. Clarification of existing regulations regarding cell therapy starting materials, including how FDA distinguishes investigational from commercial materials, expectations for collections outside the US, and how consensus standards support regulatory submissions, would also benefit the industry.
Harmonizing material receipt procedures at cell therapy production facilities, with strict temperature limits and cryopreservation media specifications, and common templates for leukapheresis manuals, SOPs, and chain-of-custody and chain-of-identity records, would further support standardization efforts.
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