Our section is involved in the standardisation and control of therapeutic immunoglobulins, large volume blood products and biotherapeutic monoclonal antibodies.
We perform Official Control Authority Batch Release (OCABR) 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.
Dr Simon E. Hufton, Section Leader Christine Ball Felicity Bentley Heather Chambers Dr Carl Dolman Ernest Ezeajughi Bernard Fox Dr Melissa Hayman Dr Sandra Prior Walter Ramage Paul Risley Graham Roberts Giles Sharp Dr Lucy StudholmeDr Luisa De Jesus Saraiva