Invention Grant
- Patent Title: Sterile affinity chromatography resin
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Application No.: US14598401Application Date: 2015-01-16
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Publication No.: US10071364B2Publication Date: 2018-09-11
- Inventor: Rahul Godawat , Veena Warikoo , Rohan Patil , Konstantin Konstantinov , Venkat Kishore Ryakala
- Applicant: Genzyme Corporation
- Applicant Address: US MA Cambridge
- Assignee: Genzyme Corporation
- Current Assignee: Genzyme Corporation
- Current Assignee Address: US MA Cambridge
- Agency: Fish & Richardson P.C.
- Main IPC: A61L2/08
- IPC: A61L2/08 ; B01J20/34 ; B01D15/36 ; B01D15/38 ; B01J20/26 ; B01J20/281 ; B01J41/12 ; B01J41/20 ; C07K1/16 ; C07K1/22 ; C07K1/18 ; B01D15/18 ; B01D15/20 ; B01D15/32 ; B01D15/34 ; B01J39/26

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
- US20150202595A1 Sterile Chromatography Resin and Use Thereof in Manufacturing Processes Public/Granted day:2015-07-23
Information query
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