Abstract
Recent years have seen unprecedented investment in research and development for countermeasures for high-threat pathogens, including specific and ambitious objectives for development of diagnostics, therapeutics, and vaccines. The inadequate availability of biological reference materials for these pathogens poses a genuine obstacle in pursuit of these objectives, and the lack of a comprehensive and equitable framework for developing reference materials is a weakness. We outline the need for internationally standardized biological materials for high-threat pathogens as a core element of global health security. We also outline the key components of a framework for addressing this deficiency.
Highlights
Recent years have seen unprecedented investment in research and development for countermeasures for high-threat pathogens, including specific and ambitious objectives for development of diagnostics, therapeutics, and vaccines
History of Biological Standardization The concept of biological standardization and the use of biological reference materials has existed since the turn of the 20th century after simultaneous discovery of diphtheria antitoxin by von Behring and Roux [3,4]
In the 1920s, the League of Nations initiated the provision of International reference preparations (IRPs) under the Commission on Biological Standardization, and biological standardization was subsequently incorporated into the constitution of the World Health Organization (WHO) upon its creation in 1946 [7]
Summary
Recent years have seen unprecedented investment in research and development for countermeasures for high-threat pathogens, including specific and ambitious objectives for development of diagnostics, therapeutics, and vaccines. The Expert Committee on Biological Standardization meets annually to establish detailed recommendations and guidelines for manufacturing, licensing, and control of complex biological materials, including blood products, vaccines, and related in vitro diagnostic tests, and to maintain a catalog of IRPs to be distributed globally as required. These WHO IRPs, composed of international reference standards and other reference materials (Table 1), provide a common set of reagents that are used to ensure the quality of biological assays and medicines globally. This process enables materials to be ascribed defined units of biological activity, most commonly international units
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