WHO is drafting a guideline on the quality and manufacture of monoclonal antibodies (mAbs), as well as a separate regulatory guidance document on the safety and efficacy evaluation of mAbs and antibody mimetics (AMs) for use in the pre-exposure prophylaxis and treatment of infectious diseases. This second document will include supplements that provide additional guidance for the development and evaluation of products to specific diseases, including Covid-19 and RSV.
Currently, the principle WHO guidance for mAbs is the Guidelines on the quality, safety and efficacy of biotherapeutic protein products prepared by recombinant DNA technology (1), although several other guidelines are also relevant to mAbs and AMs for infectious diseases (2-6). To assist in the drafting process of the new guidance documents we are seeking to identify information contained within the existing guidelines which may be missing, out of date, have insufficient detail, or require additional clarity in their application for the use in the quality, safety or efficacy of mAbs and AMs for infectious diseases. We would also like to identify any regulatory considerations that may be unique to the clinical evaluation of mAbs, AMs, or DNA/RNA-encoded mAbs directed to Covid-19 or RSV.
Please use the attached form to provide your comments and input to this process and return it to Dr Richard Is brucker (isbruckerr@who.int) prior to 15 February 2021. Draft documents based on this input will be subject of further consultation in 2021.