CN114746441A - 阳离子交换色谱期间的高盐加载调节以去除产物相关杂质 - Google Patents

阳离子交换色谱期间的高盐加载调节以去除产物相关杂质 Download PDF

Info

Publication number
CN114746441A
CN114746441A CN202080077935.3A CN202080077935A CN114746441A CN 114746441 A CN114746441 A CN 114746441A CN 202080077935 A CN202080077935 A CN 202080077935A CN 114746441 A CN114746441 A CN 114746441A
Authority
CN
China
Prior art keywords
sodium chloride
buffer comprises
acetate
loading
cation exchange
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
CN202080077935.3A
Other languages
English (en)
Chinese (zh)
Inventor
L·迪亚兹
N·戈麦斯
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 CN114746441A publication Critical patent/CN114746441A/zh
Pending legal-status Critical Current

Links

Images

Classifications

    • 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
    • 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
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/46Hybrid immunoglobulins
    • 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)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • Analytical Chemistry (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
CN202080077935.3A 2019-11-07 2020-11-04 阳离子交换色谱期间的高盐加载调节以去除产物相关杂质 Pending CN114746441A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962931863P 2019-11-07 2019-11-07
US62/931,863 2019-11-07
PCT/US2020/058772 WO2021091932A1 (en) 2019-11-07 2020-11-04 High salt load conditioning during cation exchange chromatography to remove product-realated impurities

Publications (1)

Publication Number Publication Date
CN114746441A true CN114746441A (zh) 2022-07-12

Family

ID=73598211

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202080077935.3A Pending CN114746441A (zh) 2019-11-07 2020-11-04 阳离子交换色谱期间的高盐加载调节以去除产物相关杂质

Country Status (13)

Country Link
US (1) US20220372070A1 (https=)
EP (1) EP4055041A1 (https=)
JP (2) JP7760500B2 (https=)
KR (1) KR20220092969A (https=)
CN (1) CN114746441A (https=)
AU (1) AU2020380256A1 (https=)
BR (1) BR112022008649A2 (https=)
CA (1) CA3160143A1 (https=)
CL (3) CL2022001168A1 (https=)
IL (1) IL292594A (https=)
MX (1) MX2022005593A (https=)
WO (1) WO2021091932A1 (https=)
ZA (1) ZA202205010B (https=)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001019970A2 (en) * 1999-09-15 2001-03-22 Eli Lilly And Company Chymotrypsin-free trypsin
CN104628846A (zh) * 2013-11-06 2015-05-20 上海中信国健药业股份有限公司 重组蛋白质的纯化方法
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
US20170306018A1 (en) * 2014-10-09 2017-10-26 Engmab Ag Bispecific antibodies against cd3epsilon and ror1

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2645739A1 (en) * 2006-03-20 2007-09-27 Medarex, Inc. Protein purification
EP2009101B1 (en) * 2006-03-31 2017-10-25 Chugai Seiyaku Kabushiki Kaisha Antibody modification method for purifying bispecific antibody
US9611325B2 (en) * 2014-07-21 2017-04-04 Wuhan Yzy Biopharma Co., Ltd. Construction and application of bispecific antibody HER2xCD3
CN119161488A (zh) * 2017-11-01 2024-12-20 中外制药株式会社 具有降低的生物活性的抗体变体和同种型
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 (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001019970A2 (en) * 1999-09-15 2001-03-22 Eli Lilly And Company Chymotrypsin-free trypsin
CN104628846A (zh) * 2013-11-06 2015-05-20 上海中信国健药业股份有限公司 重组蛋白质的纯化方法
US20170306018A1 (en) * 2014-10-09 2017-10-26 Engmab Ag Bispecific antibodies against cd3epsilon and ror1
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

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
GENERAL ELECTRIC COMPANY: "Polishing of monoclonalantibodies usingCaptoMMCImpResinbind and elutemode", 《GE HEALTHCARE BIO》, 31 March 2013 (2013-03-31), pages 1 - 9 *
KATARZYNA WRZOSEK ET AL.: "Influence of ligand density on antibody binding capacity of cation-exchange adsorbents", 《J CHROMATOGR A》, vol. 1216, no. 25, pages 5044 *
YIFENG LI: "A brief introduction of IgG-like bispecific antibody purification: Methods for .removing product-related impurities", 《PROTEIN EXPRESSION AND PURIFICATION》, 1 December 2018 (2018-12-01), pages 112 *
沈伊勤: "单克隆抗体聚体与碎片的去除与纯度检测方法的优化——融合蛋白X中碎片去除工艺的研究", ,《中国优秀硕士学位论文全文数据库 医药卫生科技辑》, pages 059 - 185 *

Also Published As

Publication number Publication date
CL2022001168A1 (es) 2023-01-27
EP4055041A1 (en) 2022-09-14
MX2022005593A (es) 2022-06-09
WO2021091932A1 (en) 2021-05-14
CL2024001788A1 (es) 2024-09-27
JP2022554282A (ja) 2022-12-28
AU2020380256A1 (en) 2022-06-09
CL2025003712A1 (es) 2026-01-09
IL292594A (en) 2022-07-01
KR20220092969A (ko) 2022-07-04
JP7760500B2 (ja) 2025-10-27
BR112022008649A2 (pt) 2022-07-19
CA3160143A1 (en) 2021-05-14
US20220372070A1 (en) 2022-11-24
ZA202205010B (en) 2023-01-25
JP2026012744A (ja) 2026-01-27

Similar Documents

Publication Publication Date Title
AU2020216108B2 (en) A continuous manufacturing process for biologics manufacturing by integration of drug substance and drug product processes
WO2008085988A1 (en) Methods of purifying proteins
US20230058276A1 (en) Methods for harvesting biomolecules
WO2022072291A1 (en) Cation exchange chromatography process
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
HK40070045A (en) High salt load conditioning during cation exchange chromatography to remove product-realated impurities
CN114746441A (zh) 阳离子交换色谱期间的高盐加载调节以去除产物相关杂质
US20260070943A1 (en) A method for harvesting products from high cell density perfusion cell cultures
HK40070589A (en) High salt washes during cation exchange chromatography to remove product-realated impurities
EA047099B1 (ru) Кондиционирование с высокой солевой нагрузкой в ходе катионообменной хроматографии для удаления связанных с продуктом примесей
EA046702B1 (ru) Способы очистки биспецифических антител при помощи катионообменной хроматографии с использованием промывки с высоким содержанием соли
WO2025251034A1 (en) Purification method
HK40051082A (en) A continuous manufacturing process for biologics manufacturing by integration of drug substance and drug product processes
EA049616B1 (ru) Непрерывный способ изготовления биопрепаратов посредством интеграции процессов получения лекарственного вещества и лекарственного препарата

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
REG Reference to a national code

Ref country code: HK

Ref legal event code: DE

Ref document number: 40070045

Country of ref document: HK