Biological medicines (vaccines and therapeutics) or diagnostic markers are more complex than small molecules. In most cases they cannot be characterised using standard physicochemical methods alone, nor can their activity be quantified in System Internationale (SI) units (e.g. mass), so they must be measured using biological or immunological assays. These assays use complex biological systems and are therefore inherently variable. Use of common biological reference materials of known potency to express biological activity ensures better harmonisation of products and tests across laboratories and regions.
Since the early 1970s, NIBSC has been a world leader in the production and distribution of biological reference materials including World Health Organisation (WHO) International Biological Reference Standards (IBRS) which are used to ensure the quality of biological medicines and diagnostics worldwide. NIBSC develops and distributes >90% of WHO IBRS, in accordance with the WHO “Recommendations for the preparation, characterisation, establishment and use of WHO international biological reference standards”.
As part of its role as an Essential Regulatory Laboratory for Influenza, NIBSC also produces reagents that are used to standardise the potency assay for seasonal and pandemic influenza vaccines. Click here for a list of the latest flu reagents.
NIBSC also develops, produces and distributes a wide range of working standards, reagents and control materials that are intended for use across a wide range of analytical methods. Browse our catalogue and order products.
For more information about use of NIBSC biological reference materials, please read our FAQs.
Prior to their establishment and entry into the NIBSC catalogue, the fitness for purpose of a candidate WHO IBRS is evaluated in an international multi-laboratory collaborative study carried out in accordance with the WHO recommendations (section A.8). See our list of upcoming collaborative studies for which we welcome expressions of interest to participate, together with a contact email for each study.