CA3160208A1 - High salt washes during cation exchange chromatography to remove product-realated impurities - Google Patents

High salt washes during cation exchange chromatography to remove product-realated impurities

Info

Publication number
CA3160208A1
CA3160208A1 CA3160208A CA3160208A CA3160208A1 CA 3160208 A1 CA3160208 A1 CA 3160208A1 CA 3160208 A CA3160208 A CA 3160208A CA 3160208 A CA3160208 A CA 3160208A CA 3160208 A1 CA3160208 A1 CA 3160208A1
Authority
CA
Canada
Prior art keywords
sodium chloride
wash buffer
cation exchange
acetate
wash
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CA3160208A
Other languages
English (en)
French (fr)
Inventor
Malhar R. AMBHAIKAR
Luis Diaz
Natalia GOMEZ
Benjamin J. Tillotson
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Amgen Inc
Original Assignee
Amgen Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Amgen Inc filed Critical Amgen Inc
Publication of CA3160208A1 publication Critical patent/CA3160208A1/en
Pending legal-status Critical Current

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/06Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065Purification, fragmentation
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • C07K1/18Ion-exchange chromatography
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/26Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/36Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction, e.g. ion-exchange, ion-pair, ion-suppression or ion-exclusion
    • B01D15/361Ion-exchange
    • B01D15/362Cation-exchange
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/26Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/38Selective 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
    • B01D15/3804Affinity chromatography
    • B01D15/3809Affinity chromatography of the antigen-antibody type, e.g. protein A, G or L chromatography
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/42Selective adsorption, e.g. chromatography characterised by the development mode, e.g. by displacement or by elution
    • B01D15/424Elution mode
    • B01D15/426Specific type of solvent
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D61/00Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/14Ultrafiltration; Microfiltration
    • B01D61/145Ultrafiltration
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/46Hybrid immunoglobulins
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/46Hybrid immunoglobulins
    • C07K16/468Immunoglobulins having two or more different antigen binding sites, e.g. multifunctional antibodies
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D2315/00Details relating to the membrane module operation
    • B01D2315/16Diafiltration
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/60Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/64Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising a combination of variable region and constant region components

Landscapes

  • 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)
CA3160208A 2019-11-07 2020-11-04 High salt washes during cation exchange chromatography to remove product-realated impurities Pending CA3160208A1 (en)

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

Publications (1)

Publication Number Publication Date
CA3160208A1 true CA3160208A1 (en) 2021-05-14

Family

ID=73598212

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3160208A Pending CA3160208A1 (en) 2019-11-07 2020-11-04 High salt washes during cation exchange chromatography to remove product-realated impurities

Country Status (14)

Country Link
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

Family Cites Families (12)

* 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
ES2533266T5 (es) * 2007-10-30 2018-04-18 Genentech, Inc. Purificación de anticuerpos mediante cromatografía de intercambio catiónico
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
EP3177643B1 (en) * 2014-08-04 2019-05-08 F.Hoffmann-La Roche Ag Bispecific t cell activating antigen binding molecules
EP3204415B1 (en) * 2014-10-09 2020-06-17 EngMab Sàrl Bispecific antibodies against cd3epsilon and ror1
JP6699085B2 (ja) * 2015-03-25 2020-05-27 東ソー株式会社 Fc結合性タンパク質の精製方法
EP4549463A3 (en) * 2016-06-17 2025-07-30 F. Hoffmann-La Roche AG Purification of multispecific antibodies
JP2020525445A (ja) * 2017-06-21 2020-08-27 セファロン・インコーポレイテッドCephalon,Incorporated カチオン交換クロマトグラフィーの洗浄緩衝液
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

Also Published As

Publication number Publication date
US20220372071A1 (en) 2022-11-24
CL2024001792A1 (es) 2024-11-08
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
JP2022554283A (ja) 2022-12-28
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

Similar Documents

Publication Publication Date Title
JP2022523025A (ja) 原薬及び製剤プロセスの統合による生物製剤製造のための連続的な製造プロセス
WO2022072291A1 (en) Cation exchange chromatography process
US20230058276A1 (en) Methods for harvesting biomolecules
JP2026048656A (ja) 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
US20240174752A1 (en) Modulating product quality of asymmetric multispecific antibodies through the use of temperature
US20260070943A1 (en) A method for harvesting products from high cell density perfusion cell cultures
JP7760500B2 (ja) 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負荷コンディショニング
EA046702B1 (ru) Способы очистки биспецифических антител при помощи катионообменной хроматографии с использованием промывки с высоким содержанием соли
EA047099B1 (ru) Кондиционирование с высокой солевой нагрузкой в ходе катионообменной хроматографии для удаления связанных с продуктом примесей
HK40070589A (en) High salt washes during cation exchange chromatography to remove product-realated impurities
HK40070045A (en) High salt load conditioning during cation exchange chromatography to remove product-realated impurities
WO2025251034A1 (en) Purification method
JP2026505293A (ja) 細胞培養法
EA049616B1 (ru) Непрерывный способ изготовления биопрепаратов посредством интеграции процессов получения лекарственного вещества и лекарственного препарата

Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20220823

MFA Maintenance fee for application paid

Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 4TH ANNIV.) - STANDARD

Year of fee payment: 4

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20241104

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT DETERMINED COMPLIANT

Effective date: 20241104

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20241104

D15 Examination report completed

Free format text: ST27 STATUS EVENT CODE: A-2-2-D10-D15-D126 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: EXAMINER'S REPORT

Effective date: 20241113

P11 Amendment of application requested

Free format text: ST27 STATUS EVENT CODE: A-2-2-P10-P11-P100 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: AMENDMENT RECEIVED - RESPONSE TO EXAMINER'S REQUISITION

Effective date: 20250313

W00 Other event occurred

Free format text: ST27 STATUS EVENT CODE: A-2-2-W10-W00-W111 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: CORRESPONDENT DETERMINED COMPLIANT

Effective date: 20250314

P11 Amendment of application requested

Free format text: ST27 STATUS EVENT CODE: A-2-2-P10-P11-P102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: AMENDMENT DETERMINED COMPLIANT

Effective date: 20250606

P13 Application amended

Free format text: ST27 STATUS EVENT CODE: A-2-2-P10-P13-X000 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: APPLICATION AMENDED

Effective date: 20250606

MFA Maintenance fee for application paid

Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 5TH ANNIV.) - STANDARD

Year of fee payment: 5

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20251022

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20251022