WHO Expert Committee on Biological Standardization

This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biological products used in medicine, and the establishment of international biological reference materials. Following a brief introduction, the report summarizes a number of issues brought to the attention of the Committee at its meeting held virtually in March 2024. Of particular relevance to manufacturers and national regulatory authorities are the discussions held on the development and adoption of new and revised WHO Recommendations, Guidelines and guidance documents. Following these discussions, the WHO document entitled Nonclinical and clinical evaluation of monoclonal antibodies and related products intended for the prevention or treatment of COVID-19 was adopted. Subsequent sections of the report provide information on the current status, proposed development and establishment of international reference materials in the areas of: biotherapeutics
other than blood products; blood products and related substances; in vitro diagnostics; standards for use in high throughput sequencing technologies; and vaccines and related substances. A series of annexes is then presented which includes an updated list of all WHO Recommendations, Guidelines and other documents related to the manufacture, quality control and evaluation of biological products (Annex 1).