A new scientific article on the outcome of a recently concluded Biological Standardisation Programme (BSP) study has been published in Pharmeuropa Bio & Scientific Notes 2022.
Four replacement batches of the European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for Human immunoglobulin for anticomplementary activity were established in a collaborative study and adopted by the Ph. Eur. Commission in June 2021.
The published article includes details of the method used, statistical analysis and study results. It is available on the Pharmeuropa Bio & Scientific Notes website of the European Directorate for the Quality of Medicines & HealthCare (EDQM) and is referenced on Medline/PubMed® (ID: 35384837).