WHO/BS/2019.2367 WHO IS for Tetanus immunoglobulin (human)

Overview

This report describes the outcome of a project to develop a replacement World Health Organization (WHO) International Standard (IS) and European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for tetanus immunoglobulin human (TIg). Bulk TIg was kindly provided by a European manufacturer and was used to prepare the candidate standard. The candidate standard was freeze-dried and calibrated in an international collaborative study coordinated by NIBSC and EDQM. The results of this study show that there was good agreement between laboratories for the potency estimates obtained for the candidate standard relative to the current WHO IS/Ph. Eur. BRP. The study also demonstrated that the candidate standard is suitable for use in Pharmacopoeia assays that are used for potency testing of TIg products and there was good agreement in the potency estimates obtained using the different assay methods included in the study. Accelerated degradation studies performed at NIBSC over a period of 4 years suggest that the freeze-dried candidate standard will be very stable. Results of a commutability study performed at NIBSC suggest that the candidate standard is commutable with patient samples across a range of tetanus immunoassays. It is proposed that the candidate standard is established as the 2nd WHO International Standard for Tetanus Immunoglobulin Human with an assigned value of 45 IU/ampoule.