Preparation of lyophilized and liquid intravenous immunoglobulin G: development and scale-up.
OBJECTIVE
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.


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.


CONCLUSIONS
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.
Sisti
A M
AM
Laboratorio de Hemoderivados, National University of Cordoba, Argentina. amsisti@hemo.unc.edu.ar
Vitali
M S
MS
Manfredi
M J
MJ
Zarzur
J A
JA
D005612:Freeze Drying; D006801:Humans; D007074:Immunoglobulin G; D016756:Immunoglobulins, Intravenous
D007074:Immunoglobulin G; D016756:Immunoglobulins, Intravenous