Guideline for the production and quality control of monoclonal antibodies and related products intended for medicinal use

Overview

This WHO guideline is intended to provide regulatory considerations and requirements for the marketing authorization of monoclonal antibodies (mAbs) and related products based on an immunoglobulin framework. These include mAbs of all isotypes, whether they are humanized, human, or chimeric; antibody fragments; single domain antibodies, bispecific or multispecific antibodies; Fc-fusion proteins; conjugated and chemically modified mAbs; and mAb substances which have been co-formulated within a final product. As well, the guideline is intended to apply regardless of the intended therapeutic mechanism of action, route of administration, or whether they are considered as an originator product or a biosimilar. The general principles contained within this guideline also apply to non-traditional, or novel, expression systems, such as from plants, cell-free systems, or transgenic animals.