LAUSR

The ability to quantify the activity of cytokines is an essential part of experimental and clinical investigation and is largely dependent upon the availability of suitable cytokine standards and reference reagents. The International Cytokine and Interferon Society (ICIS) Standards Committee was established to make recommendations regarding interferon and cytokine standards and standardization to the ICIS membership, and thereby to the international cytokine scientific community. The Committee works closely with the World Health Organization (WHO), the National Institute for Biological Standards and Control (NIBSC), the U.S. National Institutes of Health (NIH), the Biodefense and Emerging Infections Resources Repository (BEI Resources), pharmaceutical manufacturers, and regulatory agencies. TheCommittee includesmembers from several of these organizations. The role that the Committee plays as a source of information and recommendations to the ICIS membership, and to the international cytokine scientific community as a whole, is very much dependent upon suitable standards and reference materials being made available by the NIBSC. Similarly, the Standardization and Nomenclature Committee of the ICIS reviews the need for cytokine standards and their usage. With the expanding role of cytokines and growth factors in the development andmanufacture of biotechnology-derived products, for example, monoclonal antibodies targeting cytokines/growth factors, biosimilar medicines, cell and/or gene therapy products, the need for suitable standards is increasing. Table 1 lists WHO International Standards (ISs), WHO reference reagents (WRR), and other cytokine and growth factor standards available from the NIBSC. ISs and WRRs are publicly available reference standards with defined units (International Unit for IS) established by the WHO Expert Committee on Biological Standardization. Lyophilized and formulated to ensure long-term stability, they serve as “primary” standards for bioactivity and for calibration of secondary reference standards. The use of IS andWRR to calibrate commercially available or laboratory-made reagents including immunoassays where feasible as perWHO recommendations facilitates comparisons of data between assays, different laboratories, and individual studies allowing global harmonization. A wide range of WHO International Biological Standards and reference materials are available for the calibration of assays of therapeutic substances and immunoassays and bioassays used in basic research. These materials are available from Standards Processing Division, NIBSC, Blanche Lane, South Mimms, Potters Bar, Herts EN6 3QG, UK. The NIBSC does not charge for these materials; however, there is a handling charge to cover the costs of administration, storTABLE 1 Cytokine and Growth Factor standards and reference reagents available from the National Institute for Biological Standards and Control