Vox Sanguinis (2018) ORIGINAL PAPER © 2018 International Society of Blood Transfusion DOI: 10.1111/vox.12697 In vitro quality of amotosalen-UVA pathogen-inactivated mini-pool plasma prepared from whole blood stored overnight Catherine Ravanat, 1 Arnaud Dupuis, 1 Nadine Marpaux, 2 Christian Naegelen, 2 Guillaume Mourey, 2,3 Herve Isola, 1 Michel Lafor^ et, 1 Pascal Morel 2,3 & Christian Gachet 1 1 Universit e de Strasbourg, INSERM, EFS Grand-Est, BPPS UMR-S1255, FMTS, Strasbourg, France 2 EFS Bourgogne-Franche-Comt e, UMR1098, Besanc ßon, France 3 Universit e Bourgogne Franche Comt e, INSERM, EFS Bourgogne-Franche-Comt e, UMR1098, Besanc ßon, France Received: 14 December 2017, revised 26 June 2018, accepted 28 June 2018 Background and objectives Small 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 inac- tivation 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. Materials and methods WB-donations (~450 ml) stored overnight were processed to prepare five leucocyte-depleted plasma mini-pools (1300 ml), which were divided into two parts and treated with AUVA. Each mini-pool yielded six AUVA-plasma units (200 ml) which were frozen (-25°C) within 19 h of WB-col- lection. Their hemostatic quality was evaluated before and after treatment for up to 12 months of storage. Results Immediately 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%). How- ever, TG was similar in treated and untreated plasma at all-time-points. Conclusions Frozen WB-derived AUVA-plasma prepared from mini-pools within 19 h of WB-collection met the quality standards required for TP and retained hemostatic capacity for up to 12 months. This product could provide a cost- effective convenient substitute for apheresis plasma. Key words: pathogen inactivation, plasma, quality control, hemostasis. Introduction The transfusion of fresh frozen plasma (FFP) is indicated to correct deficiencies of hemostasis when specific factor concentrates are not available and the deficiency is asso- ciated with a significant risk of bleeding, for example in cases of organ transplant [1], trauma [2], surgery or dis- seminated intravascular coagulation. It is also used for plasma exchange in patients with thrombotic thrombocy- topenic purpura and to reverse warfarin therapy when surgery cannot be postponed [3, 4]. Moreover, plasma contains proteins with therapeutic ben- efits unrelated to hemostasis such as protective effects on the endothelium [5]. Transfusion of plasma has been postu- lated to reduce vascular endothelial permeability, inflamma- tion and organ oedema after haemorrhagic trauma [4]. Correspondence: Catherine Ravanat, Universit  e de Strasbourg, INSERM, EFS Grand-Est, BPPS UMR-S1255, FMTS, Strasbourg, France E-mail: Catherine.ravanat@efs.sante.fr 1