Invention Application
US20150202595A1 Sterile Chromatography Resin and Use Thereof in Manufacturing Processes
审中-公开
无菌色谱树脂及其在制造过程中的应用
- Patent Title: Sterile Chromatography Resin and Use Thereof in Manufacturing Processes
- Patent Title (中): 无菌色谱树脂及其在制造过程中的应用
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Application No.: US14598401Application Date: 2015-01-16
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Publication No.: US20150202595A1Publication Date: 2015-07-23
- Inventor: Rahul Godawat , Veena Warikoo , Rohan Patil , Konstantin Konstantinov , Venkat Kishore Ryakala
- Applicant: Genzyme Corporation
- Main IPC: B01J20/34
- IPC: B01J20/34 ; B01J20/281 ; B01J41/20 ; B01D15/36 ; C07K1/16 ; C07K1/22 ; B01D15/38 ; B01J41/12 ; B01J20/26

Abstract:
Provided herein are methods of reducing bioburden of (e.g., sterilizing) a chromatography resin that include exposing a container including a composition including a chromatography resin and at least one antioxidant agent and/or chelator to a dose of gamma-irradiation sufficient to reduce the bioburden of the container and the chromatography resin, where the at least one antioxidant agent and/or chelator are present in an amount sufficient to ameliorate the loss of binding capacity of the chromatography resin after/upon exposure to the dose of gamma-irradiation. Also provided are reduced bioburden chromatography columns including the reduced bioburden chromatography resin, compositions including a chromatography resin and at least one chelator and/or antioxidant agent, methods of performing reduced bioburden column chromatography using one of these reduced bioburden chromatography columns, and integrated, closed, and continuous processes for reduced bioburden manufacturing of a purified recombinant protein.
Public/Granted literature
- US10071364B2 Sterile affinity chromatography resin Public/Granted day:2018-09-11
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