Stabilized immunoglobulin and method of preparation

Details Stabilized immunoglobulin and method of preparation Stabilized immunoglobulin and method of preparation

A - Human Necessities

61

K

167/139

A61K 39/395 (2006.01) A61K 47/18 (2006.01)

Patent

CA 1285225

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 7Ø A pH value of about 6.4 is most preferred. Conductivity of the preparations is about 2 to about 4 millisiemens at 5°C., preferably about 2.5 to about 3.5 millisiemens at 5°C., and most preferably about 2.7 millisiemens at 5°C.

499148

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