title: Collaborative study to establish human immunoglobulin BRP batch 3 and human immunoglobulin (molecular size) BRP batch 1.
abstract: A study was carried out by the European Directorate for the Quality of Medicines (EDQM) as part of the joint Biological Standardisation Programme of the Council of Europe and the European Commission with the aim to establish replacement batches of the European Pharmacopoeia (Ph. Eur.) human immunoglobulin Biological Reference Preparation (BRP) batch 2. Twenty-eight laboratories participated in this study. The suitability of the candidate reference preparations to serve as working references in the tests for distribution of the molecular size, anticomplementary activity and Fc function, in accordance with the specifications of the Ph. Eur. monographs Human normal immunoglobulin for intravenous administration (0918), Human normal immunoglobulin (0338) and Anti-T lymphocyte immunoglobulin for human use, animal (1928) was demonstrated. The candidates were therefore established as human immunoglobulin BRP batch 3 and Human immunoglobulin (molecular size) BRP batch 1. The prescribed use of the latter BRP is limited to the test for distribution of molecular size.
authors.affiliation: Danish Medicines Agency, 2300 Copenhagen S, Denmark.
authors.forename: E
authors.initials: E
authors.lastname: Sandberg
authors.forename: A
authors.initials: A
authors.lastname: Daas
authors.forename: M-E
authors.initials: ME
authors.lastname: Behr-Gross
mesh_terms: D000818:Animals; D000961:Antilymphocyte Serum / Q000737:chemistry / Q000302:isolation & purification; D002138:Calibration; D003167:Complement Activation; D003165:Complement System Proteins / Q000737:chemistry / Q000592:standards; D005060:Europe; D006801:Humans; D007141:Immunoglobulin Fc Fragments / Q000737:chemistry / Q000302:isolation & purification; D008970:Molecular Weight; D010602:Pharmacopoeias as Topic; D012015:Reference Standards
chemical_list: D000961:Antilymphocyte Serum; D007141:Immunoglobulin Fc Fragments; D003165:Complement System Proteins