Title:
無菌クロマトグラフィー樹脂および製造方法におけるその使用
Document Type and Number:
Japanese Patent JP6560236
Kind Code:
B2
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.
Inventors:
LaFour Godawatt
Venus Walliko
Rohan Pattil
Konstantin Konstantinov
Venkat Kishore Riakara
Venus Walliko
Rohan Pattil
Konstantin Konstantinov
Venkat Kishore Riakara
Application Number:
JP2016546935A
Publication Date:
August 14, 2019
Filing Date:
January 16, 2015
Export Citation:
Assignee:
GENZYME CORPORATION
International Classes:
B01J20/281; A61L2/08; B01D15/34; B01D15/36; B01D15/38; B01J20/26; B01J20/34; G01N30/50
Domestic Patent References:
| JP2013515251A | ||||
| JP2008518885A | ||||
| JP2013509216A | ||||
| JP2012521776A | ||||
| JP2013544524A | ||||
| JP2013527473A | ||||
| JP2006300965A |
Foreign References:
| WO2003045546A1 | ||||
| US20120125847 | ||||
| EP2682168A1 |
Other References:
DEGENHARDT ANDREAS et al.,SEPARATION AND PURIFICATION OF ANTHOCYANINS BY HIGH-SPEED COUNTERCURRENT CHROMATOGRAPHY AND SCREENING FOR ANTIOXIDANT ACTIVITY,JOURNAL OF AGRICULTURAL AND FOOD CHEMISTRY,米国,AMERICAN CHEMICAL SOCIETY,2000年 2月 1日,VOL:48, NR:2,PAGE(S):338 - 343,URL,http://dx.doi.org/10.1021/jf990876t
KOSTOVA ALBENA et al.,PREPARATIVE CHROMATOGRAPHIC SEPARATION OF AMINO ACID RACEMIC MIXTURES I. ADSORPTION ISOTHERMS,SEPARATION AND PURIFICATION TECHNOLOGY,ELSEVIER SCIENCE B.V,2007年 5月 1日,VOL:54, NR:3,PAGE(S):340 - 348,URL,http://dx.doi.org/10.1016/j.seppur.2006.10.005
STYSKIN E L et al.,GAS CHROMATOGRAPHY OF PHENOLIC ANTIOXIDANTS,JOURNAL OF CHROMATOGRAPHY,NL,ELSEVIER SCIENCE PUBLISHERS B.V.,1973年 3月14日,VOL:77, NR:1,PAGE(S):11 - 19,URL,http://dx.doi.org/10.1016/S0021-9673(00)93926-8
KOSTOVA ALBENA et al.,PREPARATIVE CHROMATOGRAPHIC SEPARATION OF AMINO ACID RACEMIC MIXTURES I. ADSORPTION ISOTHERMS,SEPARATION AND PURIFICATION TECHNOLOGY,ELSEVIER SCIENCE B.V,2007年 5月 1日,VOL:54, NR:3,PAGE(S):340 - 348,URL,http://dx.doi.org/10.1016/j.seppur.2006.10.005
STYSKIN E L et al.,GAS CHROMATOGRAPHY OF PHENOLIC ANTIOXIDANTS,JOURNAL OF CHROMATOGRAPHY,NL,ELSEVIER SCIENCE PUBLISHERS B.V.,1973年 3月14日,VOL:77, NR:1,PAGE(S):11 - 19,URL,http://dx.doi.org/10.1016/S0021-9673(00)93926-8
Attorney, Agent or Firm:
Junji Yuda
Noriyuki Takebayashi
Noriyuki Takebayashi