Alpha Therapeutic Corporation

Prabir Bhattacharya

Toshiharu Motokubota

John Mark Rolf

Norman M Fedalizo

Shawn D Latham

David P Kosow

T (Tom) Taniguchi

Akimasa Ohmizu

Yahiro (Roy) Uemura

Charles F Sternburg

John M Rolf

A process for inactivating viral contaminants of lyophilized Factor VIII by heat is provided. The process comprises forming a stable complex between the Factor VIII and a cyclodextrin in an aqueous solution. The solution is then lyophilized, and the Factor VIII/cyclodextrin complex is recovered. The lyophilized Factor VIII/cyclodextrin is then heated to 60&deg; C. to inactivate any virus present. The material may then be reconstituted prior to administration to a patient.

Process for viral inactivation of lyophilized blood proteins

The present invention is directed to a process for purifying &agr;,-proteinase inhibitor. The process comprises providing an impure protein fraction which comprises &agr;,-proteinase inhibitor. The impure protein fraction is precipitated with a precipitant comprising PEG. The supernatant from the PEG precipitation, which comprises &agr;,-proteinase inhibitor, is collected and applied to an anion-exchange medium. A fraction comprising &agr;,-proteinase inhibitor is recovered from the anion-exchange medium and applied to a metal chelate medium. A fraction comprising &agr;,-proteinase inhibitor is then recovered from the metal chelate medium. Alpha,-proteinase inhibitor purified by the process has a specific activity greater than 0.6 units/mg.

Process for separating &agr;1-proteinase inhibitor from cohn fraction IV1 and IV4 paste

Method for obtaining highly purified transferrin from a partially purified plasma fraction containing transferrin in which the starting fraction is concentrated. Its ionic strength is reduced and then transferrin is adsorbed onto a chromatographic column. Following elution, the transferrin can be further processed through to packaging in final containers. The final purified transferrin product is sterile, at least 95% pure and is substantially free of enveloped and non-enveloped viruses.

Manufacturing process for the production of purified transferrin

A new method for purifying Factor VIII complex from an impure protein fraction, usually cryoprecipitate, is disclosed. The cryoprecipitate is dissolved in a heparin solution. Then Factor VIII complex is initially purified by polyethylene glycol precipitation. The Factor VIII containing supernatant collected after the precipitation is loaded into an anion exchange column that has a quaternary amino ethyl group. The Factor VIII complex is then eluted from the column with a buffer comprising from about 0.14M to about 0.20M CaCl.sub.2. The final step in the purification is to precipitate the Factor VIII complex in the presence of glycine and sodium chloride. The precipitated Factor VIII complex is then reconstituted and stabilized. The reconstituted Factor VIII complex can then be lyophilized and dry heated to obtain a final Factor VIII product.

Anion exchange process for the purification of Factor VIII

A process for facilitating the reconstitution of lyophilized Factor VIII complex compositions, and compositions of Factor VIII complex, which are readily reconstituted. The process of the present invention comprises providing a purified Factor VIII complex preparations; adding a stabilization agent comprising arginine; lyophilizing the stabilization agent-Factor VIII complex solutions; and reconstituting the lyophilized stabilization agent-Factor VIII complex by contacting it with solvent for less than one minute.

Solubilization and stabilization of factor VIII complex

There is provided in accordance with the practice of this invention, a process for separating Factor VIII complex from an impure protein fraction containing Factor VIII complex. An aqueous solution of the impure protein fraction containing Factor VIII complex is applied to a heparin coupled chromatographic medium to bind the Factor VIII complex to the medium. The Factor VIII is then recovered from the heparin coupled chromatographic medium by elution with an aqueous CaCl.sub.2 solution.

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Walnut, CA, United States of America

Prabir Bhattacharya