Optimized pathogen reduction of double-dose platelets pooled from seven buffy coats using the TACSI® system.

Abstract

Background and objectives: Pathogen reduction technologies (PRTs) can enhance platelet safety by mitigating pathogenic contamination risks. This study describes, for the first time, the in vitro platelet quality and function assessment of whole blood-derived double-dose (DD) pools, prepared using seven buffy coats (BCs) pooled on the Terumo Automated Centrifuge & Separator Integration (TACSI)® system and pathogen-reduced (PR) with the INTERCEPT™ Blood System (IBS).

Materials and methods: DD platelet pools were prepared by pooling seven ABO-identical BCs with 280 mL of additive solution platelet additive solution E using the TACSI® system. Process optimization ensured compliance with the European Directorate for the Quality of Medicines (EDQM) guidelines and IBS entry specifications. Units were split and either treated with IBS or left untreated, and stored agitated in INTERCEPT storage bags at 22°C for 8 days. Platelet quality was assessed at baseline and at Days 2, 6 and 8 using quality control tests and flow cytometry.

Results: All units complied with EDQM specifications. Platelet concentration significantly decreased in IBS-treated platelets (p < 0.05). Both IBS-treated and untreated platelet units exhibited similar stability for mean platelet volume (MPV), gas exchange and pH. Higher glucose values were detected in IBS-treated platelets. CD62P expression and phosphatidylserine (PS) exposure significantly increased over storage in both groups, indicating comparable storage lesion and apoptosis, respectively. No differences were observed in the pro-coagulant activity of platelets, as both groups were responsive to agonist stimulation.

Conclusion: The findings support the use of the IBS for pathogen reduction in larger platelet pools and highlight the system's effectiveness in maintaining platelet functionality for transfusion purposes.