In vitro evaluation of apheresis platelet and plasma products collected and stored in non-DEHP disposable sets.

BACKGROUND AND

OBJECTIVES

Di(2-ethylhexyl) phthalate (DEHP) has been classified as a reproductive toxicant and endocrine disruptor and will be banned in the European Union (EU) in blood bags starting in July 2030. Alternative plasticizers are being developed, and this study is the first to report on platelets and plasma collected using investigational non-DEHP apheresis sets.

MATERIALS AND

METHODS

Randomized, crossover collections of platelet and plasma products from identical participants in DEHP and non-DEHP sets were performed. Plasma was studied as fresh frozen plasma (FFP) and stored in non-DEHP bags. Additional plasma-only collections evaluated plasma frozen within 24 h after phlebotomy and held at room temperature for up to 24 h (PF24RT24). Platelet and plasma quality parameters were evaluated against the US Food and Drug Administration (FDA) and the European Directorate for the Quality of Medicines & HealthCare (EDQM) criteria.

RESULTS

Platelet products (n = 33 pairs) met all FDA/EDQM standards, and in vitro parameters were within the predetermined 20% equivalency margin. FFP products (n = 33 pairs) met the EDQM criteria. Factor VIII retention after ≥30 days of frozen storage was on average 88.4%. All parameters for PF24RT24 products (n = 31 pairs) met the 20% equivalency margin after >31 days of frozen storage. No serious adverse events in study participants were reported.

CONCLUSION

Non-DEHP apheresis disposable sets collect transfusion-quality platelet and plasma components, supporting the phasing out of DEHP and reducing exposure to this plasticizer, without compromising participant safety and quality of the collected products.