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The patent badge is an abbreviated version of the USPTO patent document. The patent badge does contain a link to the full patent document.

The patent badge is an abbreviated version of the USPTO patent document. The patent badge covers the following: Patent number, Date patent was issued, Date patent was filed, Title of the patent, Applicant, Inventor, Assignee, Attorney firm, Primary examiner, Assistant examiner, CPCs, and Abstract. The patent badge does contain a link to the full patent document (in Adobe Acrobat format, aka pdf). To download or print any patent click here.

Patent No.:

US 11839861 B1

PDFFull Text
Date of Patent:
Dec. 12, 2023

Filed:

Jan. 14, 2021

Sterile chromatography resin and use thereof in manufacturing processes

Applicant:

Genzyme Corporation, Cambridge, MA (US);

Inventors:

Rahul Godawat, Bridgewater, NJ (US);

Veena Warikoo, Bridgewater, NJ (US);

Rohan Patil, Bridgewater, NJ (US);

Konstantin Konstantinov, Bridgewater, NJ (US);

Venkat Kishore Ryakala, Bridgewater, NJ (US);

Assignee:

Genzyme Corporation, Cambridge, MA (US);

Attorney:

Fish & Richardson P.C.

Primary Examiner:

Edward J Cain

Int. Cl.
CPC ...
B01J 20/281 (2006.01); B01J 20/34 (2006.01); B01D 15/18 (2006.01); B01D 15/20 (2006.01); B01D 15/32 (2006.01); B01D 15/34 (2006.01); B01D 15/36 (2006.01); B01J 39/26 (2006.01); B01D 15/38 (2006.01); B01J 20/26 (2006.01); B01J 41/12 (2017.01); B01J 41/20 (2006.01); C07K 1/16 (2006.01); C07K 1/22 (2006.01); A61L 2/08 (2006.01); C07K 1/18 (2006.01);
U.S. Cl.
CPC ...
B01J 20/3441 (2013.01); A61L 2/081 (2013.01); B01D 15/1864 (2013.01); B01D 15/20 (2013.01); B01D 15/327 (2013.01); B01D 15/34 (2013.01); B01D 15/362 (2013.01); B01D 15/363 (2013.01); B01D 15/3804 (2013.01); B01J 20/265 (2013.01); B01J 20/281 (2013.01); B01J 39/26 (2013.01); B01J 41/12 (2013.01); B01J 41/20 (2013.01); C07K 1/16 (2013.01); C07K 1/18 (2013.01); C07K 1/22 (2013.01); Y10T 29/49826 (2015.01);
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.

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