Nonclinical and clinical evaluation of monoclonal antibodies and related products intended for the prevention of respiratory syncytial virus disease
Addendum to Annex 2 of WHO Technical Report Series, No. 1048
4 December 2024
| Technical document
Overview
Evaluating the safety and efficacy of monoclonal antibodies (mAbs) and related products intended for the prevention or treatment of infectious diseases requires different considerations than mAb products that target endogenous proteins, such as those intended for the treatment of noncommunicable diseases. To help address such differences, the WHO Guidelines on the nonclinical and clinical evaluation of monoclonal antibodies and related products intended for the prevention or treatment of infectious diseases (1) was adopted in 2023 on the recommendation of the WHO Expert Committee on Biological Standardization. These Guidelines outline the general principles applicable to the evaluation of mAbs for use against infectious diseases. Although the document provides guidance on evaluating the safety and efficacy of mAb products regardless of the targeted pathogen, it was recognized that pathogen specific considerations would potentially affect the interpretation and application of the guidance provided.
WHO Team
Health Product Policy and Standards (HPS),
Norms and Standards for Biological Products (NSB),
Technical Standards and Specifications (TSS)
Number of pages
25
Copyright
World Health Organization CC BY-NC-SA 3.0 IGO