Invention Grant
- Patent Title: Stabilization of factor VIII without calcium as an excipient
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Application No.: US15120274Application Date: 2015-03-30
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Publication No.: US09855319B2Publication Date: 2018-01-02
- Inventor: Rajiv Nayar
- Applicant: Advantech Bioscience Farmacêutica LTDA
- Applicant Address: BR San Paulo
- Assignee: ADVANTECH BIOSCIENCE FARMACÊUTICA LTDA
- Current Assignee: ADVANTECH BIOSCIENCE FARMACÊUTICA LTDA
- Current Assignee Address: BR San Paulo
- Agency: Lathrop Gage LLP
- Agent James H. Velema, Esq.
- International Application: PCT/BR2015/000045 WO 20150330
- International Announcement: WO2015/149144 WO 20151008
- Main IPC: A61K38/37
- IPC: A61K38/37 ; A61K9/19 ; A61K47/18 ; A61K47/02 ; A61K47/26

Abstract:
The present invention provides a novel albumin-free formulation of recombinant Factor VIII that does not require calcium ions as an added formulation excipient. The absence of calcium chloride in the formulation results in a number of improvements and benefits for a Factor VIII formulation. This invention allows a Factor VIII formulation that can be lyophilized more efficiently as the absence of calcium ions will increase primary glass transition of the amorphous phase. The absence of free calcium ions in the formulation will also improve the stability of the formulation as metal-dependent oxidation reactions will be avoided and the protein molecule will not be subjected to chemical instabilities. Finally, the absence of calcium will further simplify the Factor VIII formulation by reducing the number of excipients in the formulation.
Public/Granted literature
- US20170080059A1 STABILIZATION OF FACTOR VIII WITHOUT CALCIUM AS AN EXCIPIENT Public/Granted day:2017-03-23
Information query
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