Cutter Laboratories, Inc.

Miles Inc.

Miles Laboratories, Inc.

John L Lundblad

Peter M Fernandes

Gautam Mitra

Donald G Wallace

Phillip M Schneider

Richard L Seng

Willis L Warner

Miriam D Budinger

Richard S Schwartz

Lipid-enveloped viruses present in purified biologically active protein products obtained from blood or cell culture systems can be inactivated by contacting the products with caprylic acid at a non-ionized concentration, pH, temperature and ionic environment sufficient to inactivate the viruses without adversely precipitating or affecting the biological activity of the protein products.

Viral inactivation process

Compositions containing thermally sensitive, therapeutically active proteins are pasteurized without substantial loss of therapeutic activity by mixing the protein composition with a pasteurization-stabilizing amount of a sugar or reduced sugar and of an amino acid prior to pasteurization. Pasteurized compositions containing therapeutically active proteins, which have heretofore been unattainable, can be prepared by the method of the invention.

Pasteurized therapeutically active protein compositions

Novel antihemophilic factor concentrates and process for making the same are disclosed. An aqueous solution of anithemophilic factor proteins is obtained, preferably by solubilizing antihemophilic factor proteins from blood plasma cryoprecipitate in water. The aqueous solution is purified to remove unwanted protein, for example, by mixing the aqueous solution with aluminum hydroxide. Then, the aqueous solution is ultrafiltered to concentrate it, mixed with buffer and saline and adjusted to an acid pH, and freeze-dried.

Antihemophilic factor concentrate

Novel compositions containing fibronectin and methods of isolating these compositions and fibronectin itself from blood plasma are disclosed.

Fibronectin compositions

Compositions containing thermally sensitive, therapeutically active proteins are pasteurized without substantial loss of therapeutic activity by mixing the protein composition with a pasteurization-stabilizing amount of a polyol prior to pasteurization. Pasteurized compositions containing therapeutically active proteins, which have heretofore been unattainable, can be prepared by the method of the invention.

There is disclosed a pharmaceutical composition for therapeutic use comprising an immune globulin and fibronectin in amounts sufficient to produce an opsonic activity in the composition that is greater than the additive opsonic activity of the individual agents or in amounts sufficient to produce a phagocytosis of infectious agents greater than the additive effect from fibronectin and immune globulin alone.

Composition having enhanced opsonic activity

Novel antihemophilic factor concentrates and process for making the same are disclosed. An aqueous solution of antihemophilic factor proteins is obtained, preferably by solubilizing antihemophilic factor proteins from blood plasma cryoprecipitate in water. The aqueous solution is purified to remove unwanted protein, for example, by mixing the aqueous solution with aluminum hydroxide. Then, the aqueous solution is ultrafiltered to concentrate it, mixed with buffer and saline and adjusted to an acid pH, and freeze-dried.

Antihemophilic factor concentrate and method for preparation

Methods are disclosed for obtaining fibronectin and antihemophilic factor in commercial quantities from blood plasma. In the disclosed methods a blood plasma fraction containing fibronectin and antihemophilic factor is isolated from blood plasma and then solubilized in an aqueous medium. The solution is acidified and chilled at a temperature sufficient to form an acid-chill precipitate containing a major proportion of the fibronectin and a solution containing a major proportion of the antihemophilic factor of the blood plasma fraction. Fibronectin and antihemophilic factor are then isolated respectively from the precipitate and solution.

Method of preparing fibronectin and antihemophilic factor

Composition comprising an aqueous solution of immune serum globulin and maltose, the amount of maltose being sufficient to inhibit 'shedding' of the globulin with time.

Growing community of inventors

El Cerrito, CA, United States of America

John L Lundblad