The Influenza Resource Centre (IRC) of the NIBSC has played a key role in influenza vaccine standardisation and control for over 30 years, and its scientific expertise in the field is highly respected internationally. NIBSC has a central role in supporting the selection of WHO recommended viruses for vaccine use, development of candidate influenza vaccine viruses suitable for vaccine manufacture and in the development of reagents for influenza vaccine standardisation which support quality assurance of the finished vaccine products. NIBSC is recognised by WHO as an Essential Regulatory Laboratory for developing, regulating and standardising influenza vaccines.

The main functions of the NIBSC Influenza Resource Centre are as follows:

• Viruses and reagents - NIBSC is the leading WHO International Laboratory for Biological Standards, holding and distributing different standards around the world. A major function of the IRC within NIBSC is the provision of candidate influenza vaccine viruses and associated reagents for influenza vaccine standardisation to influenza vaccine manufacturers and laboratories concerned with the control and development of influenza vaccine.

• Vaccine batch release - NIBSC is the UK’s Official Medicines Control Laboratory (OMCL) for biological medicines, as designated by the Council of Europe’s European Directorate for the Quality of Medicines and Healthcare (EDQM). Assuring the safety of influenza vaccines by IRC batch release activities is particularly critical because the vaccines are used in very large numbers of individuals during national immunisation programmes. NIBSC is accredited to ISO/IEC 17025 for compliance testing of biological medicines including influenza vaccine batch release.

• Pandemic response - IRC staff responded positively and rapidly in 2004 to a request from the WHO to develop a human candidate influenza vaccine virus against the avian H5N1 virus that was spreading rapidly in South-East Asia. Due to the pathogenic nature of wild type H5N1 virus, it had to be handled in our BSL4 high containment laboratory, whilst the technique of reverse genetics was used to make a safe vaccine virus that grew well in eggs. The NIBRG-14 virus and reagents for influenza vaccine standardisation derived from it are now being used worldwide in clinical trials of human H5N1 vaccine. The IRC continues to respond to the emergence of new H5N1 viruses by developing new candidate influenza vaccine viruses as they are needed.

• Research - research to improve NIBRG-14, to generate a library of pandemic candidate influenza vaccine viruses and corresponding reagents and to test novel pandemic vaccines all feature in the IRC research programme. IRC research is state-of-the-art and recognised internationally; it attracts outside funding from bodies such as:
  • EU DG Research (for the rapid development of a pandemic vaccine strain through the project FLUPAN),
  • UK Medical Research Council (MRC) (for improving antigen yield of pandemic vaccine strains),
  • EU DG Research (for investigating novel pandemic vaccine strains through the projects PANFLUVAC and NASPANVAC),

• Control and Standardisation of new influenza vaccines - The IRC helps to assure the safety and efficacy of influenza vaccines while helping to minimise the time taken to bring new products into clinical use. New influenza vaccines, such as cell culture vaccines, adjuvanted vaccines and vaccines developed to combat pandemic influenza all require novel approaches for their control and standardisation. The IRC works with vaccine manufacturers, national and European regulatory authorities, WHO and research funding agencies to initiate research at NIBSC or to coordinate international collaborative studies.

Contract work

• IRC staff are international experts with a high level of experience in influenza serology, immunogenicity and challenge studies, influenza molecular analyses and reagent preparation. The IRC can provide this resource to outside organisations on a contract basis. Please contact our business manager at enquiries@nibsc.ac.uk for further information.

Expert Advice

• The expertise of IRC staff is recognised worldwide by governments, international agencies and the vaccine manufacturing industry and staff are often called upon for the provision of advice. Expert advice is provided to bodies such as the UK Dept of Health, the UK Medicines and Healthcare Products Regulatory Agency (MHRA), the European Medicines Agency (EMEA), the World Health Organisation (WHO) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).

The provision of goods and services by NIBSC

• The National Institute for Biological Standards and Control (NIBSC) is a not-for-profit, public body whose purpose is to safeguard and enhance public health through the standardisation and control of biologicals used in medicine.
• NIBSC produces and supplies over 90% of all WHO International Standards introduced for the quality assurance of biological medicines. These International Standards are provided free-of-charge (with the exception of third party shipping charges) to National Control Laboratories. Other recipients are charged a ‘handling’ charge’ which is calculated on a cost-recovery basis. NIBSC’s seasonal influenza reagents are charged on the same basis as the WHO International Standards.
• The Institute’s scientists possess world leading know-how relating to the standardisation of biological medicines, and we receive requests from external organisations related to this expertise.
• NIBSC provides advice to third parties, in some cases on a free-of-charge basis. In other instances it is appropriate for NIBSC to charge commercial organisations for its products and services in line with guidance issued from HM Treasury (‘Fees & Charges Guide’ and ‘Selling into Wider Markets’). NIBSC endeavours to make the same products and services equally available to commercial organisations, without prejudice.

• All external contract work is assessed with respect to potential conflicts of interest. Where there is a significant risk of a conflict of interest the work is either declined, or the conflict of interest is managed using a transparent, auditable framework