Human platelet lysate standardization across three independent European blood establishments.

ABSTRACT: Human platelet lysate (hPL) is a clinically safe alternative to fetal bovine serum (FBS). However, variability in blood donation practices, platelet concentrate preparation methods, storage and hPL manufacturing complicates standardization across jurisdictions. This study aimed to establish a first multinational hPL manufacturing standardization across three European blood centers to test feasibility and variability. A single batch of hPL production sets was distributed to the participating centers. There, hPL was produced following a single standard operating protocol but starting from each center's unique platelet concentrates. Each center prepared four 'national' hPL batches and four 'international' batches. Researchers conducted blinded quality and variation analyses to ensure unbiased

SUBMITTER: Delabie W 

PROVIDER: S-EPMC12210671 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature