Histidine stabilized immunoglobulin and method of preparation

Drug – bio-affecting and body treating compositions – Lymphokine

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424101, 530387, A61K 39395

Patent

active

045979669

ABSTRACT:
Histidine-stabilized immunoglobulin preparations and a method for their manufacture are disclosed. The present invention is particularly well suited for stabilization of human gamma globulin (IgG) preparations having a relatively low protein content. Preferred stabilized human gamma globulin preparations comprise about 5 wt-% or less gamma globulin, histidine at a concentration of about 0.025M to about 0.2M, and optionally glycine at a concentration of about 0.05M to about 0.5M. The pH value of the preparations is at least 6.0 but not more than 7.0. A pH value of about 6.4 is most preferred. Conductivity of the preparations is about 2 to about 4 millisiemens at 5.degree. C., preferably about 2.5 to about 3.5 millisiemens at 5.degree. C., and most preferably about 2.7 millisiemens at 5.degree. C.

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