Two solvent/detergent‐treated plasma products with a different biochemical profile. (23rd June 2016)

• Record Type: Journal Article
• Authors: Neisser‐Svae, A.; Heger, A.
• Is Part Of: ISBT science series. Volume 11:Number 2(2016)
• Page Start: 94
• Page End: 101
• Publication Date: 2016-06-23
• Subjects: biochemical profile -- manufacturing process -- plasma transfusion -- S/D plasma; Blood -- Periodicals; Blood -- Transfusion -- Periodicals; Immunohematology -- Periodicals; Immunopathology -- Periodicals; 615.39
• DOI: 10.1111/voxs.12282
• Languages: English
• ISSNs: 1751-2816

Abstract

Abstract : 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 OctaplasLG. In addition, the Plas+SD process was investigated in downscale studies. Results: When compared to OctaplasLG, 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 OctaplasLG 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.