Miles Laboratories, Inc.

Cutter Laboratories, Inc.

Paul K Ng

Gautam Mitra

Milton B Dobkin

Michael A Fournel

There is disclosed an improved process for producing high purity antihemophilic factor concentrate from an antihemophilic factor-containing dispersion or solution isolated from blood plasma or a blood plasma fraction, wherein the improvement is in carrying-out two consecutive precipitations using a combination of precipitants in each precipitation, first a combination of 1-4% by weight, based on weight of solution, of polyethylene glycol and 0.1-0.2 ml of 1-3%, based on weight of suspension, aluminum hydroxide suspension per gram of protein in the starting dispersion or solution, followed by a combination of added polyethylene glycol to provide a final concentration of 9-13% by weight, based on weight of the resulting solution, and 10-20% by weight of glycine, based on weight of the polyethylene glycol solution, and 10-20% by weight, based on weight of the polyethylene glycol solution, of sodium chloride.

Process for producing a high purity antihemophilic factor concentrate

Compositions containing a concentrate of coagulation Factors II, VII, IX, and X are pasteurized without substantial loss of therapeutic activity by mixing the protein composition with a pasteurization-stabilizing amount of a polyol and a source of citrate ions prior to pasteurization. Pasteurized compositions containing a concentrate of coagulation Factors II, VII, IX, and X, which have heretofore been unattainable, can be prepared by the method of the invention.

Pasteurized therapeutically active blood coagulation factor concentrates

Fraction IV, a discard fraction of the Cohn fractionation scheme, may be used as a supplement in cell growth media if the Fraction IV is rendered substantially free of components within the molecular weight range 2.5.times.10.sup.5 -1.0.times.10.sup.10, which components inhibit cell growth.

Cell growth medium supplement

Stable plasma protein fractions (PPF) substantially free of vasodepressant amounts of acetate ions are disclosed. Solutions of the disclosed PPF are suitable for intravenous administration to patients without deleterious vasodepressor effects. Methods are also described for preparing the aforementioned PPF.

Growing community of inventors

Hercules, CA, United States of America

Paul K Ng