WHO/BS/2017.2323 Report on a Collaborative Study for Proposed 1st IS for Infliximab

Overview

Two candidate preparations of infliximab were formulated and lyophilized at NIBSC prior to evaluation in a collaborative study for their suitability to serve as an international standard for the in vitro biological activity of infliximab. The study involved twenty six participants using in vitro cell-based bioassays (TNF-α neutralization, antibody dependent cellular cytotoxicity and complement dependent cytotoxicity) and binding assays. Additionally, a panel of thirty human serum samples, spiked with differing amounts of the two infliximab preparations, were assessed to evaluate the suitability of the candidate preparation for use in harmonizing methods currently in use for determining serum trough levels of infliximab in treated patients.