IL43643A - Method for production of gamma globulin - Google Patents

Abstract

1435816 Obtaining gamma globulin BAXTER LABORATORIES INC 26 Nov 1973 [27 Nov 1972] 54703/73 Heading A5B A water-soluble, intravenously administrable y-globulin is prepared by suspending whole plasma or any of Cohn Plasma Fractions II, II+III and III in normal physiological saline, adjusting the pH to 6.5 to 7.5, mixing the suspension with calcium phosphate to absorb coagulation factors, removing the precipitate and subjecting the supernatant to three successive precipitations by addition of a watersoluble block copolymer of ethylene oxide and propylene oxide comprising at least 50% ethylene oxide and having a polyoxypropylene hydrophobic base molecular weight of at least 950, the first at a pH of 4 to 5 with a final concentration of 6 to 8.5% block copolymer; the second at a pH of 4.5 to 5.5 and a final concentration 8.5% to 10%, and the third at a pH of 6.5 to 7.5 and a final concentration of 14 to 16%, the supernatant from the first two precipitations being retained and the third precipitate being the required product. If whole plasma Cohn Fraction II+III are used, the starting material is preferably subjected to an initial precipitation step at pH 6.5 to 7.5 to a concentration of 12 to 16% to remove albumin which remains in the supernatant whilst the globulins are precipitated. [GB1435816A]

Claims (6)

WHAT IS CLAIMED IS:

1. The method of preparing a highly soluble gamma globulin concentrate suitable for intravenous administration comprising sus - pending material selected from the group consisting of whole plasma and any of Cohn Plasma Fractions 11 + ΙΠ, II and III in normal physio- logical saline, adjusting the pH to about 6. 5 to 7. 5, mixing the sus- pension with calcium phosphate to adsorb the coagulation factors, separating the resulting precipitate and subjecting the recovered supernatant to a succession of three precipitations with a block co-polymer of ethylene oxide and polyoxypropylene polymer containing at least about 50% ethylene oxide in the molecule and a polyoxypropylene hydrophobic base molecular weight of at least about 950, first at a pH of about 4 to 5 and a final concentration of about 6. 0% to 8. 5% block co-polymer with retention of the resulting supernatant for the succeed-ing step, then at a pH of about 4. 5 to 5. 5 and a final concentration of above 8. 5% to about 10% block co -polymer with retention of the result -ing supernatant for the succeeding step and then at a pH of about 6. 5 to 7. 5 and a final concentration of about 14% to 16% block co-polymer with retention of the resulting precipitate as the active gamma globulin con-centrate.

2. The method of Claim 1 in which the block co-polymer con-tains about 80% of polyoxyethylene hydrophilic units in the molecule and the polyoxypropylene hydrophobic base has a molecular weight of 950.

3. The method of Claim 1 including the additional step of sub-jecting the supernatant separated from the adsorbed coagulation factors to an initial precipitation with said block co-polymer at a pH of about 6. 5 to 7. 5 and a final concentration of about 12% to 16% block co-polymer with retention of the resulting precipitate for the succeeding step.

4. The method of Claim 3 in which the block co-polymer contains about 80% of polyoxyethylene hydrophilic units in the mole-cule and the polyoxypropopylene hydrophobic base has a molecular weight of 950.

5. The method of Claim 3 in which the starting material is whole plasma including the additional step of subjecting said whole plasma to an initial precipitation with said block co-polymer at a pH of about 6. 5 to 7. 5 to a final concentration of about 13% to 16% block co-polymer with retention of the resulting precipitate for the succeeding step.

6. The method of Claim 5 in which the block co-polymer contains about 80% of polyoxyethylene hydrophilic units in the mole-cule and the polyoxypropylene hydrophobic base has a molecular weight of 950. For to* Applicants