The National Institute for Biological Standards and Control (NIBSC) plays a major national and international role in assuring the quality of biological medicines through:
We play a key role in providing scientific advice and expertise to a large number of organisations, including:
Contributions from NIBSC scientists, as members of key decision-making bodies at both European and international level, feed into the development of national and international policies that help to ensure the safety and efficacy of biological medicines.
We serve a broad range of customers and stakeholders in the UK and abroad and have a worldwide reputation for independence, integrity and scientific excellence.
The Institute is the UK’s Official Medicines Control Laboratory (OMCL), responsible for carrying out independent official batch release testing of biological medicines as required by EU law.
Biological medicines and vaccines are usually very complex materials. In order to ensure that these products are both safe and effective it is necessary to thoroughly evaluate their quality and biological activity. Each batch is examined and approved, independently from the manufacturers, and issued with a EU/EEA OCABR certificate before being released onto the market.
Biological substances used in healthcare include bacterial and viral vaccines against diseases such as:
They also include therapeutic products derived from human blood such as clotting factors and immunoglobulins, as well as other products such as monoclonal antibodies, hormones, cytokines and growth factors.
We work closely with MHRA and other European regulators for this work.
We have a leading international role in preparing, evaluating and distributing international biological standards and other biological reference materials, supplying over 90% of these for the World Health Organisation (WHO). The complex assays used to assure the potency of biologicals require the use of a standard of biological activity - a batch of substance that has been assigned units of activity and is used as a ’benchmark’.
The effective use of vaccines, most biotechnology products in therapy and many other biologicals depends on the availability of international biological standards supplied by NIBSC.
In addition to standards for WHO, NIBSC holds over 2,000 reagents managed by the Centre for AIDS Reagents (CFAR). The CJD Resource Centre supplies characterised materials for studying and developing diagnostic tests for Creutzfeldt-Jakob Disease (CJD).
NIBSC carries out an active high-quality research programme directly related to its strategic aims, carried out by internationally respected scientists, attracting significant external funding and generating an impressive publication output.
Through the Institute’s testing and evaluation activities, NIBSC’s scientists help to ensure the safety and efficacy of biological products while helping to minimise the time taken to bring new products into clinical use. New products have needed novel approaches for their control and development of new testing methods. You will find more information about the wide range of research activities that we carry out in the science and research pages. The vast potential increase in the numbers and complexity of biologicals, as a result of the genomics revolution will demand further developments in testing methods and strategies.
We are the leading WHO Collaborating Centre and International Laboratory for Biological Standards, Essential Regulatory Laboratory (ERL) for Influenza, WHO Collaborating Centre for Reference & Research on Poliomyelitis and the WHO Global Specialised Polio Network Laboratory.
We occupy a unique international position as the interface between: