VERFAHREN ZUR HERSTELLUNG VON GAMMA-GLOBULIN ZUR INTRAVENOESEN ANWENDUNG

Gamma-globulin (I) prod. for intravenous admin. contains 2-10% native (I), opt. with buffer and opt. with sugar and water for injection. The prod. is at pH 7 +- 0.05; it has an osmolarity of 300-330 mosmol/l, anticompliment activity of 10 units/ml or less, based on a protein concn. of 5% and purity of HPLC of at least 99%. Specifically, impure (I) is pptd. from blood or blood prods. and then dissolved in a soln., e.g. in water or buffer at ionic concn. 0.001-0.015 mole/l, and salts present in the impure (I) may provide the appropriate concn. The (I) is dissolved at 1-7 wt.%. A hydrocolloid may also be included, e.g. hydroxyethyl starch. Undissolved material is removed, then polyethylene glycol is added, e.g. of molecular wt. 4000 to 4-5%. Then the ppte. is sepd. and the polyethylene glycol concn. is increased, e.g. to 9.5-11%, to ppte. the (I). It is sepd. and used for intravenous admin.