Abstract: A process for the viral inactivation of lyophilized blood proteins, particularly Factor VIII, by heat comprising forming a stable complex between the blood protein and a cyclodextrin in an aqueous solution. The solution is then lyophilized and the blood protein/cyclodextrin complex is recovered. The lyophilized blood protein/cyclodextrin is then heated, e.g., to 80° C. for 72 hours, to inactivate any virus present. The material may then be reconstituted prior to administration to a patient.
Type:
Application
Filed:
June 28, 2001
Publication date:
November 29, 2001
Applicant:
Alpha Therapeutic Group
Inventors:
Prabir Bhattacharya, Toshiharu Motokubota, Norman M. Fedalizo