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. 2020 Sep;60(9):2058-2066.
doi: 10.1111/trf.15926. Epub 2020 Jul 3.

Pathogen reduction of double-dose platelet concentrates from pools of eight buffy coats: Product quality, safety, and economic aspects

Konrad Rosskopf  1 , Wolfgang Helmberg  1 , Peter Schlenke  1
Affiliations

Pathogen reduction of double-dose platelet concentrates from pools of eight buffy coats: Product quality, safety, and economic aspects

Konrad Rosskopf et al. Transfusion. 2020 Sep.

Abstract

Background: Pathogen reduction (PR) of platelet concentrates (PCs) contributes to the safety of platelet (PLT) transfusion by reducing the risk of transfusion-transmitted infections and transfusion-associated graft-versus-host disease. In vitro quality of pathogen-reduced double-dose PC (PR-PC) made of eight whole blood (WB)-derived buffy coats (BCs) were evaluated.

Methods: Eight small-volume WB BCs from donors with at least 200 × 109 PLT/L were pooled with an additive solution to produce double-dose PCs (DD-PCs), which were treated with amotosalen/ultraviolet A light in a dual storage processing set, yielding 2 units of PR-PC. Quality controls were undertaken as per European Directive for the Quality of Medicines (EDQM) guidelines. PLT recovery rates were measured. Production costs and savings were compared over the 3 years before and after PR implementation.

Results: In the pre-PR period, 19 666 PCs were produced, compared to 17 307 PCs in the PR period. Single BC in the PR period had 41 ± 2 mL, hematocrit 0.39 ± 0.04 and 1.06 ± 0.18 × 1011 PLTs, and showed a recovery of 91% ± 8%. After pooling, separation, PR treatment of DD-PC, and splitting, each single PC had 189 ± 6 mL with 2.52 ± 0.34 × 1011 PLTs, compared to 2.48 ± 0.40 in the pre-PR period. The PLT recovery rate after PR was 87% ± 14%. EDQM requirements were met. An increase of about €12 (+7.5%) per PC from the pre-PR to the PR period was identified.

Conclusion: A new production method resulting in two PR-PCs made from pools of 8 BCs with use of one PR set was successfully introduced, and our experience of nearly 3 years demonstrated the high efficacy and in vitro quality of the PR-PCs obtained.

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Conflict of interest statement

The Graz Blood Center performs company‐funded trials for Cerus and is under contract to perform routine PR for platelets and plasma in. KR and WH declare no conflicts of interest. PS has received honorarium and reinbursement for travel expenses in the past 5 years.

Figures

FIGURE 1
FIGURE 1
Process of preparation and storage of BC‐PC in the pre‐PR and PR period [Color figure can be viewed at wileyonlinelibrary.com]
FIGURE 2
FIGURE 2
Comparison of working time for conventional and pathogen reduced PC (20 end products for each group) [Color figure can be viewed at wileyonlinelibrary.com]
FIGURE 3
FIGURE 3
Health economics. Comparison of the costs and savings of the pre‐PR and PR period by platelet concentrate [Color figure can be viewed at wileyonlinelibrary.com]
See this image and copyright information in PMC

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