NIBSC has an international role in the strategic development and implementation of policies and practices designed to improve the safety and efficacy of therapeutic immunoglobulins with regulatory organisations such as EDQM and CBER/FDA, and the pharmaceutical industry.  This role includes the development of pharmacopoeial methods, monographs and specifications, the production of associated reference materials, the promotion of international harmonisation, and provision of expert scientific advice.

Pharmacopoeial methods developed at NIBSC:

• Test for anti-D antibodies in human immunoglobulin for intravenous administration. General Chapter 2.6.26, Eur. Ph.

• Assay of human anti-D immunoglobulin 2.7.13, Eur. Ph.

• Anti-A and anti-B haemagglutinins Method B: direct method 2.6.20

NIBSC has taken part in EDQM run biological standardisation programs for immunoglobulins, and has taken part in PTS for various OMCL batch release tests such as HPLC of immunoglobulins, protein estimation of immunoglobulins and the polymers and aggregates (HPLC) test for albumins.

NIBSC also train international visitors from EU and non-EU countries in batch release testing of immunoglobulins