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

• Tác giả: S Jorajuria, S Jouette, D Le Tallec, C Milne, A Niewiadomska-Cimicka
• Ngôn ngữ: eng
• Thông tin xuất bản: France : Pharmeuropa bio & scientific notes , 2025
• Bộ sưu tập: NCBI
• ID: 50705

Tóm tắt

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