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Three
generations of immunoglobulin G preparations for clinical use.
McCue
JP, Hein RH, Tenold
R Rev
Infect Dis 1986 Jul-Aug;8 Suppl 4:S374-81
The
first purified human immunoglobulin G (IgG) preparation used clinically was
immune serum globulin (ISG), which was prepared in the 1940s by E. J. Cohn's
group. It was originally formulated in water with 0.3 M glycine at pH 6.8 and
was 70%-80% monomeric. ISG was safe when given intramuscularly and efficacious
for measles and hepatitis prophylaxis. The next generation of purified IgG began
in the 1960s with chemically modified preparations suitable for intravenous
administration. The first such IgG intravenous preparation (IGIV) in the United
States was IGIV pH 6.8 (Gamimune, Cutter Biological), in which the
anticomplement activity found in ISG was removed by reduction and alkylation of
disulfide bridges. This product was originally formulated as a 5% IgG solution
in water (pH 6.8) with 0.2 M glycine in 10% maltose for stabilization. It
remained stable for at least 2.5 years at 5 degrees C, was 80%-90% monomeric,
had virtually no anticomplement activity, was safe given intravenously, and was
efficacious for prophylaxis in agammaglobulinemic patients. A third generation
of purified IgG has since been developed; IGIV pH 4.25, (Gamimune N, Cutter
Biological), which was isolated by the Cohn method from human plasma and is safe
for intravenous use, is a 5% solution of IgG in water (pH 4.25) with 10%
maltose. The product is greater than 99%
IgG, greater than 95% monomeric, and has greater than 90% less anticomplement
activity than ISG.
PMID:
3092303, UI: 86315374
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