A pilot study comparing the purity, functionality and isoform composition of alpha-1-proteinase inhibitor (human) products

Abstract

Summary text: Objective: Alpha-1-proteinase deficiency predisposes affected individuals to early onset pulmonary emphysema, and is treated with an alpha-1-proteinase inhibitor (A1-PI) from pooled human plasma. The objective of this pilot study was to assess analytical parameters of the three A1-PI products (Aralast, Prolastin, Zemaira) that may impact on clinical efficacy, safety, and convenience. These included: purity of the preparation; nature of impurities; functionality; and isoform composition. * Aralast is a registered trademark of Baxter International Inc., Deerfield, Illinois, USA † Aralast is a registered trademark of Baxter International Inc., Deerfield, Illinois, USA ‡ Zemaira is a registered trade name of ZLB Behring, King of Prussia, Philadelphia, USAMethods: Purity was evaluated using reverse phase and size exclusion chromatography high performance liquid chromatography (RP-HPLC and SEC-HPLC), capillary zone electrophoresis (CZE), sodium dodecyl sulfate polyacrylamide gel electropho...