WHO/BS/2016.2296.Rev.1 Requests to initiate new WHO reference material projects for biotherapeutics (other than blood products)

Overview

The provision of global measurement standards is an important normative activity of WHO. Biological reference preparations that are accepted internationally enable the efficacy, quality, purity and safety of very many biological medicines, used in the prevention, treatment or diagnosis of disease or conditions, to be stated in a common language worldwide. International biological reference standards support the use of many biological and immunological assays for the quality control of a wide range of biologicals including therapeutics, blood-derived products, vaccines and immunological products of traditional types as well as those derived from modern biotechnological approaches. They also have important applications in the standardization of materials and approaches used in medical diagnostics such as diagnosing disease, monitoring therapy, blood safety, and public health applications (e.g. monitoring immune status, screening for disease or susceptibility) or otherwise characterizing biological material from individuals.

WHO biological reference standards are widely used in the development, evaluation, standardization and control of products by industry; by regulatory authorities; and also in biological research in academia and scientific organizations. They play a vital role in facilitating the transfer of laboratory science into worldwide clinical practice and the development of safe and effective biologicals.

The timely development of new reference materials and standards is critically important to harness scientific developments for new biologicals. At the same time, the active management of the existing inventory of reference preparations requires a carefully planned programme of work to replace established materials before the stock of containers, which comprises the standard, is exhausted.