Why is it being sited at NIBSC?
The National Institute for Biological Standards and Control (NIBSC) is proud to have been selected as the host for the UK Stem Cell Bank. NIBSC is a publicly-funded scientific organisation whose function is to assure the quality and safety of biological medicines (mainly vaccines and blood products).
Every batch of vaccines used in the childrens vaccination programme in the UK has been tested and approved by NIBSC. All blood-derived products used in the UK are tested at NIBSC for freedom from contaminating viruses such as hepatitis and HIV.
Through its research and development activities it has built up an international reputation, over many years, for its work on the safety and quality of biological medicines such as vaccines and blood products. It also has direct experience of developing and archiving cell lines for clinical applications. Notably, NIBSC established and distributes the MRC-5 cell line that is now in routine use around the world for the production of adult and childhood vaccines. It is therefore a natural development for the Institute to take on the role of establishing and running the UK Stem Cell Bank, and helping to ensure as far as possible that stem cell therapy is developed in an appropriate framework of quality and safety.
NIBSC has a long and distinguished history in the regulation of biological medicines. In the early 20th century UK scientists realised that the strength of certain medicines could only be assayed in relation to a preparation of known strength. One of these medicines was insulin and in the 1920s the very first standard reference material for the assay of insulin was made in the UK. Since then NIBSC has been required to expand the range of products it works on and now occupies a large and developing set of purpose-built labs in Hertfordshire.
In addition NIBSC has long experience in areas of direct relevance to the UK Stem Cell Bank, including the standardisation of cytokines and growth factors. Further standardisation activities relevant to stem cell therapy, include the preparation qualified cell banks and providing an open forum for discussion of quality and safety issues within the organ and bone marrow transplant communities in the UK health service.
NIBSC has a history of successful customer-focused supply of materials to the research community. In addition to its role in ensuring the safety and efficacy of products NIBSC operates as an International repository for several classes of materials.
The Centralised Facility for AIDS Reagents supplies research materials to scientists working on HIV research.
International Biological Standards are the Gold Standards for testing the strength of almost all biological materials and are held at NIBSC and distributed to companies, public health authorities, WHO laboratory networks and researchers world-wide.
Working reagents for use by the UK transplantation laboratories are being developed and supplied by NIBSC, in collaboration with these laboratories.