Claims for Patent: 10,822,393

Summary for Patent: 10,822,393

Title:	Process for manufacturing factor VIII having an improved ratio of FVIII:C/FVIII/AG
Abstract:	A process for manufacturing of a Factor VIII product having a ratio of FVIII:C/FVIII:Ag of at least 0.7 in the Factor VIII product by using chromatography wherein at least one chromatographic step is performed by means of employing; An affinity chromatography resin having an affinity for specifically binding of Factor VIII which is effected by an affinity ligand which is immobilised on the affinity chromatography resin, said affinity ligand is a 13 kD yeast derived Fab antibody fragment directed to the Factor VIII molecule. An anionic chromatography resin. A size exclusion resin. A Factor VIII product obtainable according to the process with a monomer content of >98% for treatment of haemophilia and avoiding formation of inhibitors.
Inventor(s):	Stefan Winge, Marina Dadaian, Erica Johansson, Birte Fuchs
Assignee:	Octapharma AG
Application Number:	US15/112,936

Details for Patent 10,822,393

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Octapharma Pharmazeutika Produktionsges.m.b.h.	NUWIQ	antihemophilic factor (recombinant)	For Injection	125555	September 04, 2015	10,822,393	2035-01-20
Octapharma Pharmazeutika Produktionsges.m.b.h.	NUWIQ	antihemophilic factor (recombinant)	For Injection	125555	July 07, 2017	10,822,393	2035-01-20
Octapharma Pharmazeutika Produktionsges.m.b.h.	NUWIQ	antihemophilic factor (recombinant)	For Injection	125555	December 07, 2021	10,822,393	2035-01-20

International Patent Family for US Patent 10,822,393

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2015107222
United States of America	2016340410
Russian Federation	2695428
Russian Federation	2016134000
South Korea	20160108553