The National Institute for Biological Standards and Control (NIBSC)

The National Institute for Biological Standards and Control (NIBSC) is a centre of Medicines and Healthcare Products Regulatory Agency (MHRA), an Agency of the UK Government’s Department of Health (DH). NIBSC’s mission is to play a major national and international role in assuring the quality of biological medicines through product testing, developing standards and reference materials, and carrying out applied research. NIBSC supports health policy development and implementation through provision of expert evidence-based advice and technical support, and are an important component of the Department of Health’s risk management strategy for public health. NIBSC is designated as the UK’s Official Medicines Control Laboratory for Biological Medicines, working closely with MHRA and operating within the European regulatory network to carry out independent official batch release testing of certain types of product as required by EU law. NIBSC is also the leading WHO International Laboratory for Biological Standards and a WHO collaborating centre. NIBSC occupies a unique international position at the interface between product manufacturers, regulators, policy makers and leading edge academic research. NIBSC serves a broad range of customers and stakeholders in the UK and abroad and has a worldwide reputation for independence, integrity and scientific excellence.

Role in the TRANSVAC project

Our roles in the project include activities in WP4, 6, 17 and 19. WP4, Task 4.5: The development of novel/ customised Luminex bead arrays will support the Luminex studies carried out in both the technology platform and the systems biology platforms. WP6, Task 6.1 and 6.3: The investigation of predictive immunogenicity and efficacy of BCG vaccination will generate data from relevant models with a regimen comparable to human immunisation. Antigen specific lymphocyte responses and cytokine secretion profiles will be assessed by advanced flow cytometry. Innovative imaging technologies to monitor responses to vaccines and infections in suitable models will provide information in characterisation of live vaccine (such as BCG) of its biodistribution and persistence. We will also contribute and support the activities in WP17 – Scientific-technical networking; and WP19, Task 19.2: Dissemination of project results to the scientific and corporate communities.

Main staff involved in TRANSVAC

Dr. Mei Mei Ho; Dr. Bhagwati Khatri;

The Facility

NIBSC has a well-established, dedicated biological facility and relevant models for evaluating the protective potencies of BCG and new TB vaccine candidates. We are also equipped with advanced imaging system technology offering non-invasive longitudinal monitoring of disease progression, cell trafficking and gene expression patterns in relevant models using non-virulent mycobacteria tagged with bioluminescense genes. Our other facilities also provide Luminex and Meso Scale Discovery (MSD) platforms for the detection of cytokines and chemokines. Our Luminex 100 and 200 systems are based on the principles of flow cytometry. In a single reaction volume, Luminex has the ability to perform many different tests and use either magnetic beads or plain polystyrene beads. It has many applications including nucleic acid assays, receptor-ligand assays, immunoassays and enzymatic assays. MSD platform is based on the principles of ELISA with MULTISPOT panels for quantifying multiple analytes simultaneously from a single, small-volume sample. The assays are provided in a pre-coated 96- or 384-well microtiter plates. Biomolecules of interest are detected using SULFO-TAG– conjugated reporter molecules by MSD instruments.

TNA or Training provided

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