Invention Grant
US08822643B2 Process for the preparation of a virus-inactivated FV concentrate starting from human plasma, scalable to industrial level
有权
从人血浆开始制备病毒灭活的FV浓缩物的方法,可扩展到工业水平
- Patent Title: Process for the preparation of a virus-inactivated FV concentrate starting from human plasma, scalable to industrial level
- Patent Title (中): 从人血浆开始制备病毒灭活的FV浓缩物的方法,可扩展到工业水平
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Application No.: US14112264Application Date: 2012-04-20
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Publication No.: US08822643B2Publication Date: 2014-09-02
- Inventor: Paola Rossi , Ilaria Nardini , Pierangelo Giovacchini , Filippo Mori , Claudio Farina
- Applicant: Paola Rossi , Ilaria Nardini , Pierangelo Giovacchini , Filippo Mori , Claudio Farina
- Applicant Address: IT Castel Vecchio Pascoli
- Assignee: Kedrion S.p.A.
- Current Assignee: Kedrion S.p.A.
- Current Assignee Address: IT Castel Vecchio Pascoli
- Agency: Abelman, Frayne & Schwab
- Priority: ITFI2011A0084 20110422
- International Application: PCT/EP2012/057262 WO 20120420
- International Announcement: WO2012/143507 WO 20121026
- Main IPC: A61K38/00
- IPC: A61K38/00 ; C07K14/745 ; C07K14/75 ; C07K1/22 ; C07K1/36 ; C07K1/18 ; G01N30/02 ; C07K1/16

Abstract:
The present invention provides a process for purifying FV starting from human plasma or a fractionation intermediate thereof, that is simple, scalable to the industrial level and relatively inexpensive compared to the methods described in the literature to date. The invention consists of the use of two anion exchange chromatography steps, the first of which has the purpose of separating the FV from the PTC component factors, while the second has the purpose of isolating the protein of interest from the majority of plasma proteins by means of selective interaction with the weak anion exchange support used. The process developed has also had a viral inactivation step and a viral removal step included, contributing to the safety of the final product obtained, without however significantly altering the process total recovery of FV, and without necessitating the introduction of additional steps for eliminating the inactivating agents used, thanks to the order in which the various steps are conducted. The process described in the present invention also enables an FV concentrate to be obtained that is stable once frozen at −20° C.
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