Armour Pharma Gmbh

Bernhard Kerner

Fumio Kurosu

Tokusuke Kimura

Jurgen Holzapfel

Martin Puschmann

Jurgen-Dietrich Friedrich-Fiechtl

An improved process for the preparation of gamma globulin suitable for intravenous administration comprises dissolving gamma globulin precipitated from blood or blood products in a solution, separating non-dissolved precipitate from the solution, adding polyethylene glycol to the separated solution, separating precipitate from the polyethylene glycol solution, increasing the polyethylene glycol concentration in the solution, separating precipitated purified gamma globulin from the higher concentrated polyethylene glycol solution, dissolving the purified gamma globulin in a solution suitable for intravenous administration, which process is improved by dissolving the gamma globulin precipitated from blood in a solution having a neutral pH, adding polyethylene glycol in the first step to a concentration of 4.0-5.5% by weight, and increasing the polyethylene glycol concentration in the second step to at least 9% but not more than 16% by weight, and by adding a buffer to the solution just prior to adding the polyethylene glycol in one of the two polyethylene glycol addition steps.

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Munster, Germany

Bernhard Kerner