Our section is involved in the standardisation and control of therapeutic immunoglobulins, large volume blood products and biotherapeutic monoclonal antibodies.
We perform National Control Authority Release (NCAR) testing of licensed immunoglobulin products and human albumin solutions, testing up to 500 batches each year. Find out more about NIBSC control testing.
We’ve also developed over 90 standards and reference preparations, including immunoglobulins and immune sera, red cell serology, haematinics, haemoglobin, allergens and biotherapeutic monoclonal antibodies.
This work is underpinned by research that combines expertise in immunology, molecular biology, immunochemistry and bioassay development.
With our vast experience in these areas we also provide advice on product testing, methodology and regulatory requirements, including setting pharmacopoeial specifications.