NIBSC autumn newsletter 2015

Ebola reference reagents produced by the National Institute for Biological Standards and Control (NIBSC) have been endorsed by the World Health Organisation (WHO) Expert Committee on Biological Standardisation as the global standards for use in laboratory tests. The reagents are now available to the scientific community.

NIBSC was asked by WHO to produce two types of Ebola reference reagents. The first is run alongside patient samples to detect Ebola infection. The second measures Ebola antibody levels following infection, or following immunisation with candidate vaccines.

The Ebola antibody standard will be used around the world in the testing of Ebola vaccines in development, and is expected to help accelerate the availability of new vaccines for this devastating disease.

Given the urgency for such materials amid the Ebola outbreak in West Africa, NIBSC fast-tracked their development and production work.

The diagnostic reagents and vaccine reagent are available to order through the NIBSC website.

NIBSC scientists have published new research that reports the case of a man from the UK who failed to eliminate the Sabin oral poliovirus after immunisation and has continued to excrete the virus for over 28 years. The research was published in PLoS Pathogens in August 2015.

NIBSC scientists are working on several international collaborative projects to tackle outstanding issues relating to polio. These include:

• maintaining high levels of surveillance and immunisation until the last poliovirus, as opposed to the last disease case, is wiped from the earth
• developing efficient anti-viral treatments to manage the possible risks of vaccine-derived strains spreading and causing disease
• developing new stable live-attenuated polio vaccines with no risk of reseeding the virus into the population, to complete eradication and respond to any poliovirus isolation in the post-eradication era

Visit our website for more information on our polio work.

The WHO Expert Committee on Biological Standardisation (ECBS) met from the 12 to 16 October 2015 and reviewed a number of completed projects from NIBSC for the establishment of new or replacement International Standards and Reference Reagents. In total, 15 new and four replacement standards/reference reagents were established. New standards include those for human C-peptide, Meningococcal polysaccharide vaccines (serogroups A and X), anti-Enterovirus 71 serum, TNF receptor II Fc fusion protein (Etanercept), anti-A and anti-B in serum and plasma, a reference panel for Erythropoietin antibody assays and DNA standards for JC virus and BK virus. In addition, new Ebola virus RNA reference reagents and run controls were established together with an anti-EBOV plasma (human) reference reagent. These new Ebola standards were developed in rapid response to the recent Ebola virus disease outbreak to support development of new Ebola vaccines and standardisation of diagnostic tests.

Replacement standards established in 2015 include those for Diphtheria Toxoid for flocculation testing, Hepatitis C virus RNA, anti-Toxoplasma Immunoglobulin, and Blood Coagulation Factor IX concentrate. In addition, ECBS endorsed proposals to assign units for holotranscobalamin to the International Standard for Vitamin B12 and Serum Folate and to assign a Factor IX antigen value to the 4th International Standard for Blood Coagulation Factors II, VII, IX, X, plasma.

Once new standards/reagents are ready for dispatch they will become available from the NIBSC website and an e-alert will be sent out. Subscribe to receive e-alerts when a new standard or reference material is available from NIBSC.

Following the announcement of the forthcoming retirement of current director, Dr Stephen Inglis, who has led the institute for the past 14 years, Dr Christian K Schneider has been appointed as the new director of NIBSC. Christian is currently head of the medical division of the Danish Health and Medicines Authority. He will join the institute on 1 January 2016 as Director designate, formally taking over as director on 1 April 2016.

Find out more about our new director

NIBSC’s senior scientific staff undertake research projects in addition to their responsibilities to produce biological standards and to carry out control testing of products. Their expertise in regulatory science, and access to specialist materials and facilities at the institute, enable them to make important contributions in this field. Recent publications include the following:

Francis N, Moore M, Asan SG, Rutter GA, Burns C (2015).Changes in microRNA expression during differentiation of embryonic and induced pluripotent stem cells to definitive endoderm. Gene Expr. Patterns. 19(1-2):70-82. doi: 10.1016/j.gep.2015.08.001

Vessillier S, Eastwood D, Fox B, Sathish J, Sethu S, Dougall T, Thorpe SJ, Thorpe R, Stebbings R (2015). Cytokine release assays for the prediction of therapeutic mAb safety in first-in man trials--Whole blood cytokine release assays are poorly predictive for TGN1412 cytokine storm. J. Immunol. Methods. 424:43-52. doi: 10.1016/j.jim.2015.04.020.

Otto RB, Burkin K, Amir SE, Crane DT, Bolgiano B (2015). Patterns of binding of aluminum-containing adjuvants to Haemophilus influenzae type b and meningococcal group C conjugate vaccines and components. Biologicals. 43(5):355-62. doi: 10.1016/j.biologicals.2015.06.008.

NIBSC provides over 90% of all WHO international standards for the quality assurance of biological medicines and diagnostic tests. The Institute continues to build on its extensive range of reference materials for use in standardising biological assays, including an increasing number of CE-marked diagnostic controls.

View our latest products including World Health Organization (WHO) International Standards, CE-marked reference materials and more.

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