Invention Grant
- Patent Title: Lyophilized factor IX formulations
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Application No.: US15128951Application Date: 2015-03-24
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Publication No.: US10772942B2Publication Date: 2020-09-15
- Inventor: Brian M. Thome , Cherie Parkhurst-Lang , Brandon W. Leveille
- Applicant: Bioverativ Therapeutics Inc.
- Applicant Address: US MA Waltham
- Assignee: Bioverativ Therapeutics Inc.
- Current Assignee: Bioverativ Therapeutics Inc.
- Current Assignee Address: US MA Waltham
- Agency: Lathrop GPM LLP
- Agent James H. Velema, Esq.
- International Application: PCT/US2015/022141 WO 20150324
- International Announcement: WO2015/148444 WO 20151001
- Main IPC: A61K38/36
- IPC: A61K38/36 ; A61K38/48 ; F26B5/06 ; A61K47/18 ; A61K9/00 ; A61K9/19 ; A61K47/22 ; A61K47/26

Abstract:
The present invention provides, among other things, pre-lyophilization formulations, reconstituted formulations, and lyophilate powder compositions comprising a Factor IX (FIX) polypeptide. The present invention also provides lyophilization methods for producing lyophilate powder comprising a FIX polypeptide. The present invention is directed to a pre-lyophilization formulation comprising: (a) a Factor IX (FIX) polypeptide having FIX coagulation activity; (b) a buffering agent; (c) a stabilizing agent; (d) a bulking agent; and (e) a surfactant, wherein the formulation has a fill volume of less than about 5 mL, and wherein each of (a)-(e) are at an amount per vial (mg/vial) sufficient to allow (1) improved stability of the FIX polypeptide when lyophilized.
Public/Granted literature
- US20170173122A1 Lyophilized Factor IX Formulations Public/Granted day:2017-06-22
Information query
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