Business Case

The Influenza Resource Centre’ building was funded by the UK Department of Health following a careful study of options, costs and benefits following HM Treasury guidelines. The approved ‘Full Business Case’ is a public document  available to read or download below.

Approved Business Case (PDF)

Pandemic H1N1 activities  (updated September 2009)

NIBSC in common with WHO Collaborating Centres and other Essential Regulatory Laboratories has been involved in development of candidate H1N1v vaccine viruses and two such viruses NIBRG-121 and NIBRG-121xp are now available for evaluation by vaccine manufacturers and other interested laboratories. NIBSC has also produced and made available reagents for standardisation of pandemic H1N1 vaccines. Details of viruses and reagents can be obtained at (link to ‘new H1N1 (swine) flu)

H5N1 Antibody International Standard (updated September 2009)

There are many clinical trials of newly-developed H5N1 vaccines taking place throughout the world. The efficacy of these vaccines is evaluated by measurement of antibody responses, but the assays used for such evaluation are not very reproducible from laboratory to laboratory. There is therefore an urgent need to standardise the assays, so that different vaccines can be properly compared for their efficacy. NIBSC was asked by the WHO Expert Committee for Biological Standardisation (ECBS) to prepare an International Standard for H5N1 antibody as soon as possible. Human plasma for this standard was donated by companies from China and Hungary and then freeze dried at NIBSC. Test sera were also obtained for use in an international collaborative study. The candidate International Standard was assessed by an international team of investigators and was found to reduce the inter-laboratory variability of H5N1 clade 1 serology assay results by about 50%. The International Standard 07/150 for antibody to H5N1 clade 1 viruses was established by ECBS in October 2008 and is available from NIBSC on request.

Meetings at NIBSC (updated September 2009)

NIBSC convenes bi-annual meetings with influenza vaccine manufacturers, Essential Regulatory Laboratories and WHO Collaborating Centres for Influenza to review and discuss topics of mutual interest and concern. Topics include a review of influenza in the world, the availability of suitable vaccine viruses and reagents for both seasonal and pandemic vaccines, and the use of reverse genetics to produce vaccine viruses. Matters arising from these meetings are taken to the WHO Information meeting following the vaccine strain selection process. The next meeting will take place at NIBSC in February 2010.

In conjunction with the bi-annual meeting in July 2007, a workshop was held on the implications of manufacturing influenza vaccine in cell culture rather than in hens’ eggs. This novel approach to flu vaccine manufacture might need dedicated vaccine potency reagents and candidate vaccine viruses; studies in this area are now in progress and they are an important part of the IRC work programme.

Meetings outside of NIBSC (updated January 2009)

The internationally renowned expertise of IRC staff takes them to many meetings and conferences on a world-wide basis, to provide advice or to disseminate their findings. In recent years IRC staff have contributed to the bi-annual WHO meetings on influenza vaccine composition, to the WHO Technical Advisory Group on the Global Action Plan to increase supply of seasonal and pandemic vaccines, to the WHO Intergovernmental Meetings on Pandemic Influenza Preparedness, to WHO pre-qualification of influenza vaccine manufacturers, to WHO meetings on the establishment of an influenza virus traceability mechanism, and to the Biologics Working Party (BWP) and Vaccine Working Party (VWP) of the EU Committee for Medicinal Products for Human Use (CHMP).

New Influenza Resource Centre building (updated January 2009)

Pandemic influenza vaccine development and the increased global scale of manufacture and usage of seasonal influenza vaccines mean increasing work for the Influenza Resource Centre (IRC). Therefore, it needs to expand from its current laboratories in the building at South Mimms, built some 20 years ago. The Department of Health recognises the high value of the influenza work performed at NIBSC and has funded the construction of a new centre, purpose-built for the various functions of the IRC. The plans for this new centre have been prepared and, following a tender process, Morgan Ashurst was selected as the contractor. The new building will house the IRC on the ground floor and the UK Stem Cell Bank on the first floor. Construction work is on-going and the move of the IRC into its new premises is expected early in 2010.

Views of the new building (September 2009)

Temporary Flu Centre (updated January 2009)

In the meantime, until the new IRC is complete, a temporary laboratory has been installed at the NIBSC site, dedicated to the generation of candidate influenza vaccine viruses which are utilised by industry in the manufacture of influenza vaccine. The viruses are generated by a process of ‘reassortment’, and almost every year due to the ever changing antigenic properties of influenza viruses, there is a need to develop a new vaccine virus based upon the surveillance data generated by the WHO’s global network of surveillance laboratories. The work of the temporary flu centre is funded by a consortium of the vaccine manufacturing industry via the IFPMA.

Recent publications (updated January 2009)

Publications.