Alpha Therapeutic Corporation

Norman M Fedalizo

Prabir Bhattacharya

Toshiharu Motokubota

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

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.

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Rowland Heights, CA, United States of America

Norman M Fedalizo