Two solvent/detergent‐treated plasma products with a different biochemical profile

Background and Objectives The distribution of US ‐produced solvent/detergent (S/D)‐treated plasma (Plas+ SD ) was discontinued in 2003 due to bleeding and thrombotic events. In this work, we were searching for explanations that might explain these severe side‐effects. Materials and Methods The activities of coagulation factors and inhibitors and von Willebrand factor ( VWF ) multimers were tested in three Plas+ SD batches and compared with an S/D‐treated plasma named Octaplas LG . In addition, the Plas+ SD process was investigated in downscale studies. Results When compared to Octaplas LG , coagulation factors (F)V and FXI were significantly increased in the Plas+ SD product, whereas FIX , protein C ( PC ), protein S ( PS ) and plasmin inhibitor ( PI ) were significantly decreased, leading to a haemostatic imbalance in this product. In addition, loss of high molecular weight VWF multimers was observed in the Plas+ SD product compared to both Octaplas LG and normal plasma. Downscale studies of the Plas+ SD manufacturing steps revealed significant losses of all parameters tested during the S/D‐treatment and removal steps. Except for PS and PI , which remained decreased by 47% and 65%, respectively, these losses were nearly compensated for the other parameters by the subsequent ultrafiltration step performed. Conclusion Although both S/D plasma manufacturing processes have the same basic set‐up, differences in single process steps are responsible for the different biochemical profiles. The study performed may contribute to a better understanding of the side‐effects that occurred with the Plas+ SD product.