Development and Validation of an Enzyme-Linked Immunosorbent Assay for the Measurement of Human Coagulation Factor XI in Human Immunoglobulin Preparations

Abstract

Following an accumulation of incidences of thromboembolic events after administration of certain immunoglobulin G (IgG) brands in 2010 and 2011, regulatory agencies also required other therapeutically used IgG preparations to be checked for the presence of procoagulant activities. Additionally, their manufacturing pathways had to be investigated for steps that have the capacity to reduce procoagulant activities.