Invention Grant
- Patent Title: Sterile chromatography resin and use thereof in manufacturing processes
-
Application No.: US16543247Application Date: 2019-08-16
-
Publication No.: US11369703B2Publication Date: 2022-06-28
- Inventor: Rohan Patil , Chad Varner
- 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 ; B01J20/26 ; B01J20/28 ; B01J20/286 ; B01J20/30 ; B01J41/04 ; B01J49/60 ; B01J47/02 ; B01J47/014 ; C07K1/18 ; B01D15/36 ; B01D15/38 ; B01J41/12

Abstract:
Provided herein are methods of reducing bioburden of a chromatography resin that include exposing a container including a composition including (i) a chromatography resin and (ii) a liquid including at least on alcohol to a dose of gamma-irradiation sufficient to reduce the bioburden of the container and the chromatography resin, where the at least one alcohol 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 a liquid including at least one alcohol, 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
- US20200069822A1 STERILE CHROMATOGRAPHY RESIN AND USE THEREOF IN MANUFACTURING PROCESSES Public/Granted day:2020-03-05
Information query
IPC分类: