無菌クロマトグラフィーおよび製造方法

Japanese Patent JP6691047

B2

Provided herein are methods of performing chromatography with gamma-irradiated chromatography resin that include providing a chromatography column including a gamma-irradiated chromatography resin; performing a first cycle of chromatography through the column, where the cycle includes exposing the chromatography resin to a denaturing buffer; and performing at least one additional cycle of chromatography through the column. Also provided are integrated, closed or substantially closed, and continuous processes for manufacturing of a recombinant protein that include the use of at least one chromatography column including gamma-irradiated chromatography resin, where the gamma-irradiated chromatography resin is exposed to denaturing buffer during each cycle in the process, and reduced bioburden buffer is used in the process.

LaFour Godawatt
Venus Walliko
Rohan Pattil
Konstantin Konstantinov
Venkat Kishore Riakara
Martha Rohani

JP2016546971A

April 28, 2020

January 16, 2015

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GENZYME CORPORATION

C07K1/18; B01D15/20; B01D15/36; C12P21/02

JP2013527473A
JP2013515258A
JP2013515251A
JP2012510981A

WO2013159858A1
WO2003045546A1

GAGNON P., DISSECTION OF THE SEPARATION MECHANISMS AND ENHANCEMENT OF AGGREGATE REMOVAL BY CHARGED-HYDROPHOBIC MIXED MODE CHROMATOGRAPHY, 6TH INTERNATIONAL SYMPOSIUM ON HIC AND RPC (2009) pp.1-30
CAPTO ADHERE - AFFINITY CHROMATOGRAPHY, GE Healthcare Life Sciences, Instructions 28-9064-05 AC (2012) [ONLINE], [検索日 2018年12月4日], pp.1-40, インターネット
BIOPROCESS INTERNATIONAL (2007) Vol.5, No.5, pp.52-56 (第53,55頁は広告頁のため削除)

Junji Yuda
Noriyuki Takebayashi

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