Universal pooled plasma (Uniplas® ) does not induce complement-mediated hemolysis of human red blood cells in vitro

Abstract Background Pooling of plasma of different blood groups before large scale manufacturing of Uniplas® results in the formation of low levels of soluble immune complexes (CIC). The aim of this study was to investigate the level and removal of CIC during Uniplas® manufacturing. In addition, an in vitro hemolysis assay should be developed and investigate if Uniplas® does induce complement-mediated hemolysis of human red blood cells (RBC). Materials and methods In-process samples from Uniplas® (universal plasma) and Octaplas(LG)® (blood group specific plasma) routine manufacturing batches were tested on CIC using commercially available ELISA test kits. In addition, CIC was produced by admixing heat-aggregated immunoglobulins or monoclonal anti-A/anti-B antibodies to plasma and removal of CIC was followed in studies of the Uniplas® manufacturing process under down-scale conditions. The extent of RBC lysis was investigated in plasma samples using the in-house hemolysis assay. Results Levels of CIC in Uniplas® are within the normal ranges for plasma and comparable to that found in Octaplas(LG)® . Down-scale experiments showed that both IgG/IgM-CIC levels are significantly removed on average by 40–50% during Uniplas® manufacturing. Uniplas® does not induce hemolysis of RBCs in vitro . Hemolysis occurs only after spiking with high titers of anti-A/anti-B antibodies and depends on the antibody specificity (i.e. titer) in the plasma sample. Conclusion The results of this study confirm the safety of Uniplas® regarding transfusion to patients of all ABO blood groups.