WHO/BS/2022.2435: Collaborative Study to Assess the Candidate 3rd International Standard for Rabies Immunoglobulin

Overview

A WHO international collaborative study was undertaken to assess the suitability of a candidate replacement WHO International Standard (IS) for Rabies Immunoglobulin for use in the standardization of potency assays, that measure neutralising antibody levels in therapeutic human rabies immunoglobulin (HRIG), and serology assays that measure antibody levels in human and animal serum. The candidate was prepared from a HRIG bulk manufactured according to Good Manufacturing Practices (GMP) guidelines, dispensed into ampoules in 0.5 mL aliquots and freeze-dried for long-term stability.