WHO Informal consultation on the guideline for the safe production and quality control of monoclonal antibodies for use in humans
13-15 December 2021
12 June 2021
| Technical document
Overview
The ability to quickly develop safe and effective monoclonal antibodies (mAbs) makes them a priority for the treatment of emerging infections such as COVID-19. However, existing WHO guidance on mAbs focuses on products targeting noncommunicable diseases and offers little advice on mAbs intended for the treatment of infectious diseases. In the context of the COVID-19 pandemic, draft guidance was developed to address this limitation and the resulting document was subject to public consultation towards the end of 2021.
WHO Team
Health Product Policy and Standards (HPS),
Norms and Standards for Biological Products (NSB),
Technical Standards and Specifications (TSS)
Number of pages
11
Copyright
World Health Organization CC BY-NC-SA 3.0 IGO