JP2022554283A - 生成物関連不純物を除去するためのカチオン交換クロマトグラフィー中の高塩分洗浄 - Google Patents

生成物関連不純物を除去するためのカチオン交換クロマトグラフィー中の高塩分洗浄 Download PDF

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JP2022554283A
JP2022554283A JP2022525320A JP2022525320A JP2022554283A JP 2022554283 A JP2022554283 A JP 2022554283A JP 2022525320 A JP2022525320 A JP 2022525320A JP 2022525320 A JP2022525320 A JP 2022525320A JP 2022554283 A JP2022554283 A JP 2022554283A
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Prior art keywords
sodium chloride
wash buffer
cation exchange
acetate
wash
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JP2022525320A
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Japanese (ja)
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JP2022554283A5 (https=
Inventor
アンバイカル，マルハール・アール
ディアス，ルイス
ゴメス，ナタリア
ティロットソン，ベンジャミン・ジェイ
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アムジエン・インコーポレーテツド
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Publication of JP2022554283A publication Critical patent/JP2022554283A/ja
Publication of JP2022554283A5 publication Critical patent/JP2022554283A5/ja
Priority to JP2025195036A priority Critical patent/JP2026048656A/ja
Pending legal-status Critical Current

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065—Purification, fragmentation
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/36—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction, e.g. ion-exchange, ion-pair, ion-suppression or ion-exclusion
    • B01D15/361—Ion-exchange
    • B01D15/362—Cation-exchange
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/38—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving specific interaction not covered by one or more of groups B01D15/265 and B01D15/30 - B01D15/36, e.g. affinity, ligand exchange or chiral chromatography
    • B01D15/3804—Affinity chromatography
    • B01D15/3809—Affinity chromatography of the antigen-antibody type, e.g. protein A, G or L chromatography
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/42—Selective adsorption, e.g. chromatography characterised by the development mode, e.g. by displacement or by elution
    • B01D15/424—Elution mode
    • B01D15/426—Specific type of solvent
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/14—Ultrafiltration; Microfiltration
    • B01D61/145—Ultrafiltration
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C07K1/18—Ion-exchange chromatography
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/46—Hybrid immunoglobulins
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/46—Hybrid immunoglobulins
    • C07K16/468—Immunoglobulins having two or more different antigen binding sites, e.g. multifunctional antibodies
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2315/00—Details relating to the membrane module operation
    • B01D2315/16—Diafiltration
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/64—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising a combination of variable region and constant region components

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Analytical Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Water Supply & Treatment (AREA)
  • Engineering & Computer Science (AREA)
  • Peptides Or Proteins (AREA)
  • Treatment Of Liquids With Adsorbents In General (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
JP2022525320A 2019-11-07 2020-11-04 生成物関連不純物を除去するためのカチオン交換クロマトグラフィー中の高塩分洗浄 Pending JP2022554283A (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2025195036A JP2026048656A (ja) 2019-11-07 2025-11-14 生成物関連不純物を除去するためのカチオン交換クロマトグラフィー中の高塩分洗浄

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962931874P 2019-11-07 2019-11-07
US62/931,874 2019-11-07
PCT/US2020/058774 WO2021091933A1 (en) 2019-11-07 2020-11-04 High salt washes during cation exchange chromatography to remove product-realated impurities

Related Child Applications (1)

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JP2025195036A Division JP2026048656A (ja) 2019-11-07 2025-11-14 生成物関連不純物を除去するためのカチオン交換クロマトグラフィー中の高塩分洗浄

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JP2022554283A true JP2022554283A (ja) 2022-12-28
JP2022554283A5 JP2022554283A5 (https=) 2023-08-14

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JP2022525320A Pending JP2022554283A (ja) 2019-11-07 2020-11-04 生成物関連不純物を除去するためのカチオン交換クロマトグラフィー中の高塩分洗浄
JP2025195036A Pending JP2026048656A (ja) 2019-11-07 2025-11-14 生成物関連不純物を除去するためのカチオン交換クロマトグラフィー中の高塩分洗浄

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US (1) US20220372071A1 (https=)
EP (1) EP4055042A1 (https=)
JP (2) JP2022554283A (https=)
KR (1) KR20220092958A (https=)
CN (1) CN114651007A (https=)
AR (1) AR120398A1 (https=)
AU (1) AU2020377919A1 (https=)
BR (1) BR112022008782A2 (https=)
CA (1) CA3160208A1 (https=)
CL (2) CL2022001169A1 (https=)
IL (1) IL292602A (https=)
MX (1) MX2022005594A (https=)
TW (2) TWI878377B (https=)
WO (1) WO2021091933A1 (https=)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4263597A2 (en) * 2020-12-18 2023-10-25 Kiniksa Pharmaceuticals, Ltd. Protein compositions and methods for producing and using the same

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2565206A2 (en) * 2007-10-30 2013-03-06 Genentech, Inc. Antibody purification by cation exchange chromatography
JP2016183113A (ja) * 2015-03-25 2016-10-20 東ソー株式会社 Ｆｃ結合性タンパク質の精製方法
JP2017525690A (ja) * 2014-08-04 2017-09-07 エフ・ホフマン−ラ・ロシュ・アクチェンゲゼルシャフト 二重特異性ｔ細胞活性化抗原結合分子
WO2017218977A2 (en) * 2016-06-17 2017-12-21 Genentech, Inc. Purification of multispecific antibodies
JP2018502050A (ja) * 2014-10-09 2018-01-25 エンクマフ アーゲー ＣＤ３εおよびＲＯＲ１に対する二特異性抗体
WO2018237159A1 (en) * 2017-06-21 2018-12-27 Cephalon, Inc. Cation exchange chromatography wash buffer

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU9034298A (en) * 1997-08-25 1999-03-16 Walter H. Runkis A simple, environmentally benign, method for purifying protein
US20120282654A1 (en) * 2009-04-29 2012-11-08 Schering Corporation Antibody purification
WO2012125735A1 (en) * 2011-03-15 2012-09-20 Abott Laboratories An integrated approach to the isolation and purification of antibodies
CN104628846B (zh) * 2013-11-06 2019-12-06 三生国健药业（上海）股份有限公司 重组蛋白质的纯化方法
WO2015198320A1 (en) * 2014-06-24 2015-12-30 Insight Biopharmaceuticals Ltd. Methods of purifying antibodies
CN110305217B (zh) * 2018-03-27 2022-03-29 广州爱思迈生物医药科技有限公司 双特异性抗体及其应用

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2565206A2 (en) * 2007-10-30 2013-03-06 Genentech, Inc. Antibody purification by cation exchange chromatography
JP2017525690A (ja) * 2014-08-04 2017-09-07 エフ・ホフマン−ラ・ロシュ・アクチェンゲゼルシャフト 二重特異性ｔ細胞活性化抗原結合分子
JP2018502050A (ja) * 2014-10-09 2018-01-25 エンクマフ アーゲー ＣＤ３εおよびＲＯＲ１に対する二特異性抗体
JP2016183113A (ja) * 2015-03-25 2016-10-20 東ソー株式会社 Ｆｃ結合性タンパク質の精製方法
WO2017218977A2 (en) * 2016-06-17 2017-12-21 Genentech, Inc. Purification of multispecific antibodies
WO2018237159A1 (en) * 2017-06-21 2018-12-27 Cephalon, Inc. Cation exchange chromatography wash buffer

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Publication number Publication date
US20220372071A1 (en) 2022-11-24
CL2024001792A1 (es) 2024-11-08
CA3160208A1 (en) 2021-05-14
IL292602A (en) 2022-07-01
BR112022008782A2 (pt) 2022-07-26
CL2022001169A1 (es) 2023-01-27
WO2021091933A1 (en) 2021-05-14
TW202132323A (zh) 2021-09-01
MX2022005594A (es) 2022-06-09
AR120398A1 (es) 2022-02-09
EP4055042A1 (en) 2022-09-14
TW202523676A (zh) 2025-06-16
JP2026048656A (ja) 2026-03-17
KR20220092958A (ko) 2022-07-04
AU2020377919A1 (en) 2022-06-16
CN114651007A (zh) 2022-06-21
TWI878377B (zh) 2025-04-01

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