Standardized Apheresis Processes Would Help Cell Therapy Sector

Variability in collection practices at sampling sites has an impact on the quality of cell therapy starting materials, say the authors of new analysis, who suggest that a degree of standardization would aid industry.

Biological factors, such as age, disease status, treatment regimen, and donation history, impact the quality of cells harvested at collection sites, which is a challenge for cell therapy developers trying to turn these variable materials into consistent products.

But biology is not the only source of variability, according to Christina Celluzzi, PhD, from the Association for the Advancement of Blood & Biotherapies, who says firms should not underestimate the role cell collection practices play in determining quality.

“Variability at the apheresis stage complicates comparability assessments when manufacturers change processes, transfer technology, or add capacity. It also limits how efficiently sponsors can use comparability protocols and post-approval change strategies,” she tells GEN.

Standardization

Celluzzi and colleagues looked at the impact of variation in apheresis and handling protocols in a recent study, concluding that standardizing parts of these processes would aid cell and gene therapy developers.

“Not every area needs the same degree of standardization,” she says, adding, “for example, there will always need to be flexibility with regard to device selection and vascular access techniques.”

“In contrast, the elements of apheresis that support comparability and traceability would benefit most from tight standardization. These include minimum donor eligibility data elements, definitions of quality attributes, and product identification and labeling,” Celluzzi says.

She cites existing standards—such as ISBT 128, which covers terminology, labeling, and chain of identity—as an ideal starting point for industry efforts to standardize cell collection practices.

“Adoption of such standards should be paired with implementation support, so that standardization doesn’t widen capability gaps between collection sites.

“We believe the technical content of best practices is best developed by stakeholders, for example through consensus efforts led by organizations such as PDA and ASTCT. Regulators would then recognize or incorporate those standards rather than author them from scratch,” she continues.

That said, the clarification of existing regulations covering cell therapy starting materials would also help industry, according to Celluzzi.

“We’re also asking FDA to clarify several points: how it distinguishes investigational from commercial starting materials, its expectations for collections made outside the United States, and how consensus standards can support regulatory submissions.”

Harmonizing material receipt procedures at cell therapy production facilities would help too, Celluzzi says, citing strictly defined temperature limits and cryopreservation media specifications as examples.

“Common templates for leukapheresis manuals, SOPs, and chain-of-custody and chain-of-identity records would be beneficial,” Celluzzi says, adding, “Risk-based site qualification would let manufacturers focus audits on product-specific risks instead of repeatedly reassessing established quality systems.”

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