Properties of a concentrated minipool solvent‐detergent treated cryoprecipitate processed in single‐use bag systems

Abstract

Cryoprecipitate is still used to treat factor VIII (FVIII), von Willebrand factor (VWF) and/or fibrinogen deficiency. Recently a solvent-detergent (S/D) process of minipools of cryoprecipitate performed in a closed bag system has been designed to improve its viral safety. Still, cryoprecipitate has other drawbacks, including low concentration in active proteins, and presence of haemolytic isoagglutinins. We report here the biochemical evaluation of S/D-treated minipools of cryoprecipitates depleted of cryo-poor plasma. Cryoprecipitates were solubilized by 8 mL of a sterile glucose/saline solution, pooled in batches of 40 donations and subjected to S/D treatment in a plastic bag system using either 2% TnBP or 1% TnBP-1%Triton X-45, followed by oil extractions (n = 10). Mean (+/-SD) FVIII and fibrinogen content was 8.86 (+/-1.29) IU mL(-1) and 16.02 (+/-1.98) mg mL(-1), and 8.92 (+/-1.05) IU mL(-1) in cryoprecipitate minipools treated with 2% TnBP, and 17.26 (+/-1.71) mg mL(-1), in those treated by TnBP-Triton X-45, respectively. The WWF antigen, ristocetin cofactor and collagen binding activities were close to 10, 7 and 8 IU mL(-1), respectively, and were not affected by either SD treatment. VWF multimeric pattern of SD-treated cryoprecipitates were similar to that of normal plasma, and the >15 mers and >10 mers content was identical to that of the starting cryoprecipitates. The anti-A and anti-B titre was 0-1 and 0-1/8, respectively. Therefore, it is possible to prepare virally inactivated cryoprecipitate minipools depleted of isoagglutinins and enriched in functional FVIII, VWF and clottable fibrinogen.