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WO2018190677A3 - Method for purifying analogous antibody using cation-exchange chromatography - Google Patents

Method for purifying analogous antibody using cation-exchange chromatography Download PDF

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Publication number
WO2018190677A3
WO2018190677A3 PCT/KR2018/004345 KR2018004345W WO2018190677A3 WO 2018190677 A3 WO2018190677 A3 WO 2018190677A3 KR 2018004345 W KR2018004345 W KR 2018004345W WO 2018190677 A3 WO2018190677 A3 WO 2018190677A3
Authority
WO
WIPO (PCT)
Prior art keywords
exchange chromatography
purifying
cation
analogous
antibodies
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.)
Ceased
Application number
PCT/KR2018/004345
Other languages
French (fr)
Other versions
WO2018190677A2 (en
Inventor
Sung-Muk KANG
Hong Jai Lee
Kyunghwa Kim
Jung Min Yoo
Chung Min Lee
Gyung-Hwa LEE
Dong Eok Lee
Sung In Lim
Gyong-sik HA
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.)
HK Inno N Corp
Original Assignee
CJ Healthcare Corp
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 CJ Healthcare Corp filed Critical CJ Healthcare Corp
Publication of WO2018190677A2 publication Critical patent/WO2018190677A2/en
Publication of WO2018190677A3 publication Critical patent/WO2018190677A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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
    • B01D15/42—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
    • 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
    • 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
    • C07K1/22—Affinity chromatography or related techniques based upon selective absorption processes
    • 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
    • C07K1/34—Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis
    • 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
    • C07K1/36—Extraction; Separation; Purification by a combination of two or more processes of different types
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065—Purification, fragmentation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/522—CH1 domain
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2318/00—Antibody mimetics or scaffolds

Landscapes

  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Biophysics (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Water Supply & Treatment (AREA)
  • Peptides Or Proteins (AREA)

Abstract

La présente invention concerne une méthode de séparation d'impuretés d'anticorps analogues à l'aide d'une chromatographie par échange de cations et, plus particulièrement, une méthode de séparation des fragments uniques et des isoformes d'anticorps analogues, qui sont produits pendant le processus de production d'anticorps analogues, et de purification uniquement de fragments d'anticorps cibles avec une pureté et un rendement élevés à l'aide d'un tampon d'élution pour la chromatographie par échange de cations.The present invention relates to a method for separating impurities from analogous antibodies using cation exchange chromatography and, more particularly, to a method for separating single fragments and isoforms of analogous antibodies, which are produced. during the process of producing analog antibodies, and purifying only target antibody fragments with high purity and yield using an elution buffer for cation exchange chromatography.

PCT/KR2018/004345 2017-04-14 2018-04-13 Method for purifying analogous antibody using cation-exchange chromatography Ceased WO2018190677A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR10-2017-0048635 2017-04-14
KR20170048635 2017-04-14

Publications (2)

Publication Number Publication Date
WO2018190677A2 WO2018190677A2 (en) 2018-10-18
WO2018190677A3 true WO2018190677A3 (en) 2019-01-17

Family

ID=63792713

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2018/004345 Ceased WO2018190677A2 (en) 2017-04-14 2018-04-13 Method for purifying analogous antibody using cation-exchange chromatography

Country Status (4)

Country Link
KR (1) KR102140693B1 (en)
AR (1) AR111465A1 (en)
TW (1) TWI679209B (en)
WO (1) WO2018190677A2 (en)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR102209790B1 (en) * 2018-12-20 2021-02-01 에이치케이이노엔 주식회사 Method for purification of vaccine virus using affinity chromatography
CN110066314B (en) * 2019-04-01 2023-10-27 上海药明生物技术有限公司 Affinity purification process for efficiently improving separation resolution of multimer
CN114539417A (en) * 2020-11-26 2022-05-27 盛禾(中国)生物制药有限公司 Chromatographic purification process for effectively removing bispecific antibody homodimers

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20130136883A (en) * 2012-06-05 2013-12-13 씨제이제일제당 (주) A novel method for purifying long-acting human growth hormone
KR20140142974A (en) * 2013-06-05 2014-12-15 한화케미칼 주식회사 A Method of Antibody Purification
US20150056196A1 (en) * 2007-10-30 2015-02-26 Genentech, Inc. Antibody purification by cation exchange chromatography
US20160264618A1 (en) * 2013-10-30 2016-09-15 Celltrion Inc. Method for separating antibody isoforms using cation exchange chromatography
US20170066814A1 (en) * 2010-12-21 2017-03-09 Hoffmann-La Roche Inc. Isoform enriched antibody preparation and method for obtaining it

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011050071A2 (en) * 2009-10-20 2011-04-28 Abbott Laboratories Isolation and purification of anti-il-13 antibodies using protein a affinity chromatography

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150056196A1 (en) * 2007-10-30 2015-02-26 Genentech, Inc. Antibody purification by cation exchange chromatography
US20170066814A1 (en) * 2010-12-21 2017-03-09 Hoffmann-La Roche Inc. Isoform enriched antibody preparation and method for obtaining it
KR20130136883A (en) * 2012-06-05 2013-12-13 씨제이제일제당 (주) A novel method for purifying long-acting human growth hormone
KR20140142974A (en) * 2013-06-05 2014-12-15 한화케미칼 주식회사 A Method of Antibody Purification
US20160264618A1 (en) * 2013-10-30 2016-09-15 Celltrion Inc. Method for separating antibody isoforms using cation exchange chromatography

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
LEE, HONG JAI ET AL.: "Purification of antibody fragments for the reduction of charge variants using cation exchange chromatography", JOURNAL OF CHROMATOGRAPHY B, vol. 1080, 31 January 2018 (2018-01-31), pages 20 - 26, XP055566960 *

Also Published As

Publication number Publication date
KR20180116159A (en) 2018-10-24
WO2018190677A2 (en) 2018-10-18
KR102140693B1 (en) 2020-08-05
AR111465A1 (en) 2019-07-17
TW201841933A (en) 2018-12-01
TWI679209B (en) 2019-12-11

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