Premium
Preparation of lyophilized and liquid intravenous immunoglobulin G: development and scale‐up
Author(s) -
Sisti A. M.,
Vitali M. S.,
Manfredi M. J.,
Zarzur J. A.
Publication year - 2001
Publication title -
vox sanguinis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.68
H-Index - 83
eISSN - 1423-0410
pISSN - 0042-9007
DOI - 10.1046/j.1423-0410.2001.00041.x
Subject(s) - diafiltration , antibody , ultrafiltration (renal) , chromatography , pharmacopoeia , medicine , virus inactivation , chemistry , pharmacology , virus , immunology , membrane , biochemistry , microfiltration , pathology , alternative medicine
Background and Objectives Intravenous immunoglobulin G (IVIG) preparations are used in several disorders: primary and secondary immunodeficiencies, autoimmune and systemic inflammatory diseases, and in infectious diseases as effective therapy. In this work, we report a method of processing IVIG (lyophilized and liquid) from Cohn fraction II (FII) paste. Materials and Methods The process included the following steps: virus inactivation by heat in a solution of FII, ultrafiltration, treatment at pH 4 with traces of pepsin, diafiltration and final formulation. Optimizations for each step on a small scale are described. The method has been effectively scaled‐up. Results The final product contained at least 99% monomers plus dimers of IgG, a low anti‐complementary activity (AcA) < 1 CH50/mg, and the remaining quality parameters fell within the range fixed by the European Pharmacopoeia. Conclusion The method described is an effective way of preparing large quantities of IVIG (lyophilized and liquid) which fulfils the standard requirements of both the European Pharmacopoeia and the World Health Organization.