The Biological Standardisation Programme (BSP) recently established batch 2 of the Ph. Eur. Hepatitis A virus Coating Reagent Biological Reference Reagent (BRR) for use in the in vitro potency assay of hepatitis A vaccines by ELISA. The BRR was established in an international collaborative study (BSP165) and adopted by the European Pharmacopoeia Commission at its session in November 2023.

The outcome of the study, the materials and methods used and the statistical analysis of the results are detailed in an online article published in Pharmeuropa Bio & Scientific Notes.

Pharmeuropa Bio & Scientific Notes is a journal published by the EDQM and is included in MEDLINE.

More information on the BSP is available on the EDQM website.