In vitro quality of amotosalen-UVA pathogen-inactivated mini-pool plasma prepared from whole blood stored overnight

Background and objectivesMaterials and methodsSmall batch-pooled (mini-pool) whole blood (WB)-derived plasma could be an alternative cost-effective source of therapeutic plasma (TP), but carries an increased risk of transfusion-transmitted infection due to exposure of the recipient to several donors. This risk can be mitigated by inactivation of pathogens susceptible to the amotosalen-UVA (AUVA)-treatment. We evaluated the conservation of coagulation factors in AUVA-plasma prepared from WB stored overnight under routine operating conditions, to determine its therapeutic efficacy. Thrombin generation (TG) by the AUVA-plasma was used to provide an integrated measure of the hemostatic capacity. WB-donations (similar to 450ml) stored overnight were processed to prepare five leucocyte-depleted plasma mini-pools (1300ml), which were divided into two parts and treated with AUVA. Each mini-pool yielded six AUVA-plasma units (200ml) which were frozen (-25 degrees C) within 19h of WB-collection. Their hemostatic quality was evaluated before and after treatment for up to 12months of storage. ResultsConclusionsImmediately after AUVA-treatment, the regulatory criteria for FVIII activity and fibrinogen content were met. As compared to untreated plasma there was a reduction in fibrinogen (14%), FV (9%), FVII (25%) and FVIII (32%). However, TG was similar in treated and untreated plasma at all-time-points. Frozen WB-derived AUVA-plasma prepared from mini-pools within 19h of WB-collection met the quality standards required for TP and retained hemostatic capacity for up to 12months. This product could provide a cost-effective convenient substitute for apheresis plasma.