Different batches of human albumin solutions from one manufacturer may induce heterogeneous cardiovascular effects

Safety of Plasma Volume Expanders

“…88 In addition, different batches of a single product from a single manufacturer may differ in their capacity to precipitate adverse events. 89 Therefore, heterogeneity between and within products may explain the residual adverse events ascribed to albumin solutions, including the endothelial activation markers observed en vivo by Nohé et al 85 and in abdominal surgery patients by Boldt et al 90 On the basis that albumin preparations are heterogeneous and may be expected to have different safety and efficacy profiles, particularly in the extremely wide range of clinical conditions in which they are used, it is worth reflecting on the implications of the safe study, 12 which underpins the reassurance regarding the safety of albumin post the Cochrane metaanalysis. The preparation used for this study was a very high purity albumin solution prepared by chromatography and lacking many of the potential contaminants permitted by the current pharmacopeial specification of 95% purity.…”

“…The heterogeneity of albumin solutions from different manufacturers has been shown in relation to their potential to induce inflammatory reactions in endothelial cells 87 and their capacity to bind dyes 88 . In addition, different batches of a single product from a single manufacturer may differ in their capacity to precipitate adverse events 89 . Therefore, heterogeneity between and within products may explain the residual adverse events ascribed to albumin solutions, including the endothelial activation markers observed en vivo by Nohé et al 85 and in abdominal surgery patients by Boldt et al 90 …”