A PROCESS FOR VIRAL INACTIVATION OF LYOPHILIZED BLOOD PROTEINS - Patent Pending

(12) Patent Application: (11) CA 2252374
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.
(72) Inventors (Country): MOTOKUBOTA, TOSHIHARU (United States)
BHATTACHARYA, PRABIR (United States)
(73) Owners (Country): ALPHA THERAPEUTIC CORPORATION (United States)
(71) Applicants (Country): ALPHA THERAPEUTIC CORPORATION (United States)
(74) Agent: FETHERSTONHAUGH & CO.
(45) Issued:
(86) PCT Filing Date: Apr. 17, 1997
(87) PCT Publication Date: Oct. 30, 1997
Examination requested: Jan. 7 , 2002
(51) International Class (IPC): C12N 7/04
A61K 35/14
A61L 2/16
A61K 38/36
A61K 38/37
A61K 47/40
A61K 38/48
Patent Cooperation Treaty (PCT): Yes (85) National Entry: Oct. 16, 1998
(86) PCT Filing number: PCT/US1997/006585
(87) International publication number: WO1997/039761
(30) Application priority data: Application No. Country Date
08/634,921 United States Apr. 19, 1996
Availability of licence: N/A
Language of filing: English