Collaborative study for the establishment of Ph. Eur. Biological Reference Preparation for Human tetanus immunoglobulin batch 2.

Abstract

A study was organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM, Council of Europe) to establish a replacement batch for the current European Pharmacopoeia (Ph. Eur.) Human Anti-D immunoglobulin Biological Reference Preparation (BRP) batch 1 whose stocks were dwindling. The BSP176 study was run in the framework of the Biological Standardisation Programme (BSP) of the Council of Europe and the European Union (EU) Commission. In view of the current stocks, the difficulties in sourcing suitable starting materials and the time required to calibrate a replacement batch with the 3 different methods described in Ph. Eur. chapter 2.7.13. Assay of human anti-D immunoglobulin, it had been decided as an interim measure to establish BRP batch 2 (BRP2) using ampoules already qualified for use as the World Health Organization (WHO) 3^rd International Standard (IS) for anti-D immunoglobulin (16/332) and obtained from MHRA. For this purpose, a verification study has been performed at the EDQM laboratory on the candidate BRP (cBRP) material, i.e. ampoules of the 3^rd IS for anti-D immunoglobulin received at EDQM, to be used as BRP2. The study showed that the anti-D estimated potency of the cBRP, WHO 3^rd IS for anti-D Immunoglobulin, relative to BRP1 which is equivalent to the WHO 2^nd IS, was consistent with the value of 297 IU/ampoule assigned during the establishment study for the 3^rd IS and in continuity with BRP1. Stability was confirmed by checking the potency of ampoules stored at the recommended storage temperature (i.e. -20°C) against ampoules stored at -70°C since the establishment. The molecular-size distribution profile of the cBRP was also similar to the one obtained during the establishment study, again confirming the stability. All these data confirmed the good stability of the WHO 3^rd IS for anti-D Immunoglobulin in line with the stability study performed during its establishment and confirmed its suitability for use as BRP2. In October 2024, the Ph. Eur. Commission officially adopted the candidate batch as Ph. Eur. Human Anti-D immunoglobulin BRP batch 2 with an assigned potency of 297 IU/ampoule. The activity of the new batch of Ph. Eur. Anti-D immunoglobulin BRP will be regularly monitored.