HPA - National Institute for Biological Standards and Control

Dr. Barry Walker

The National Institute for Biological Standards and Control (NIBSC) is a centre of the Health Protection Agency (HPA), and its mission is to assure the quality of biological medicines.

The aims of OPTIMALVAC fall well within the expertise and mission of NIBSC. These areas include:

a) Providing standard reference reagents for immunoassays – NIBSC has an International anti-malaria antibody standard currently coming to fruition, and it is envisaged that this will be available from quite early on in the scheme of activities, and that evaluating the standard could coincide with some of these activities. NIBSC also plan to obtain and prepare some additional reference preparations for use in immunoassays, and this could be partly included. Additional standards will also be made available (mainly vivax).

b) Work on reference materials and proficiency assays is in line with current NIBSC work. We will provide and distribute reference reagents. One issue which has been particularly worrying is the small amounts of specifically-immunised sera available from volunteer studies, and it would be very useful to devise some way of obtaining larger amounts and setting up a standardised system for distributing them.

c) NIBSC has a standardization program for reference standards for ELISPOT and FACS. There is currently a collaborative FACS study revolving around ICS gamma standard preparations in which quite a number of malaria labs have been added to what was originally a TB-directed study.

In all cases NIBSC has the statistical expertise to analyze collaborative and proficiency surveys.