Quality assessment of routine produced mirasol pathogen reduction system treated platelet concentrates

ABSTRACT

Background: Prevention of transfusion-associated infections remains a challenge in transfusion medicine. The Mirasol Pathogen Reduction Technology (PRT) System uses riboflavin plus UV light to inactivate residual white blood cells and nucleic acid-containing pathogens to reduce the risk of transmission of bacteria, viruses, parasites, novel pathogens e.g SARS-CoV-2. This demonstrates the cumulative quality data of Mirasol-treated PC produced under routine conditions in our institute in the last year Methods: One hundred sixteen whole blood derived PCs, resulting from the pooling of 5 buffy coats with 250ml PAS-E solution were treated with the Mirasol technology. PCs were mixed with 35 ml Riboflavin solution and illuminated with UV-light in accordance to manufacturer's instructions. For quality control (QC) assessment the following parameters were investigated post-production (PP) and at the end of shelf-life (EOS) at days 5, 6 or 7 pH (ABL80 FLEX Blood Gas Analyzer, at 37degreeC), platelet yield (Cell- Dyn Ruby, Abbott) and CD62P-positive cells with and without TRAP-6 (100muM) using the FACS methodology with FITC-labelled CD62P antibody (Cytomics FC 500 Flow Cytometer, Beckman Coulter). Result(s) Mirasol-treated PCs showed a mean pH of 7.3 at PP and ranged 7.1 to 7.0 at EOS1. Platelet yield PP and EOS were consistent with 3.0 to 3.1 x1011 platelets (PLT)/unit. Platelet activation measured with CD62P+ expression w/o TRAP-6 was 27.7% at PP and ranged from 46.9 to 55.8 at EOS1;CD62P+ expression induced by TRAP-6 was 79.3 at PP and ranged from 72.3 to 68.1 at EOS1. Conclusion(s) The QC data on Mirasol-treated PCs produced during the past year showed encouraging results: all pH values remained far above 6.4, platelet yields remained stable suggesting min cell loss, with EOS yields always above the threshold of 2.5x1011 PLT/unit. Rates of CD62P+cells increased with time, an upregulation of CD62P+ with TRAP-6 was still detectable at EOS up to Day 7. The presented results confirm the data of the initial Mirasol validation at our site, showing the robustness of the technology. (Table Presented).