Fc function of a new intravenous immunoglobulin product: IGIV 10% triple virally inactivated solution.
OBJECTIVE
Baxter AG has developed a new liquid intravenous immunoglobulin product [Immune Globulin Intravenous (IGIV) 10%] using a new manufacturing procedure. A modified Cohn fractionation and ion exchange chromatography is used to produce an IgG solution with no alterations to the Fc region. Three dedicated virus reduction steps are included: solvent-detergent treatment, nanofiltration, and incubation at low pH and elevated temperature in final formulation. We applied the reference method of the European Pharmacopoeia (EP) together with a flow-cytometric binding assay for the evaluation of the Fc function of the new product.


METHODS
The EP reference method was done as described in the EP. The flow-cytometric method measured binding of IgG to Fc receptors of human monocytic THP-1 cells after exclusion of apoptotic cells.


RESULTS
Sixteen lots of the new product expressed Fc functions between 84% and 110% when analysed with the EP reference method and Fc-binding activities between 82% and 121% when determined by the flow-cytometric method.


CONCLUSIONS
All tested lots of the new product demonstrated a high level of Fc activity and met the requirements of the EP for Fc function.
Reipert
B M
BM
Baxter BioScience, Vienna, Austria. birgit_reipert@baxter.com
Ilas
J
J
Carnewal
C
C
Füreder
S F
SF
Bölzlbauer
U
U
Teschner
W
W
Fiedler
C
C
Schwarz
H P
HP
D005434:Flow Cytometry / Q000379:methods; D004854:Herpesvirus 4, Human; D006801:Humans; D007141:Immunoglobulin Fc Fragments / Q000032:analysis / Q000276:immunology*; D007074:Immunoglobulin G / Q000276:immunology*; D016756:Immunoglobulins, Intravenous / Q000737:chemistry* / Q000276:immunology; D009000:Monocytes / Q000821:virology; D011961:Receptors, Fc / Q000378:metabolism; D012016:Reference Values
D007141:Immunoglobulin Fc Fragments; D007074:Immunoglobulin G; D016756:Immunoglobulins, Intravenous; D011961:Receptors, Fc