Optimized Protocol for Producing Pathogen-inactivated Double-dose Platelet Concentrates From Six Pooled Buffy Coats.

ABSTRACT:

Background

Pooled platelet (PLT) production methods differ worldwide. In Europe, the buffy coat (BC) method is predominantly used, with four to eight BCs being pooled to produce single- or double-dose PLT products. The European Directorate for the Quality of Medicines & HealthCare (EDQM) blood guide and Austrian legislation define a therapeutic PLT unit as ≥ 2 × 10¹¹ PLTs/unit. We optimized the manufacturing steps to produce double-dose PLT products from six BCs, aiming to enhance production efficiency while maintaining product quality.

Methods

We stepwise optimized our protocol starting from five BCs (BC5) (N=107). First, we included an additional BC (BC6) (N=110). Second, we used a hematology analyzer (Sysmex XN-1000) equipped with blood bank mode, which is a no

SUBMITTER: Amato M 

PROVIDER: S-EPMC12535830 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature