WO2018212556A1 - Procédé de purification d'un anticorps ou d'un fragment d'anticorps de celui-ci à l'aide d'une chromatographie d'affinité - Google Patents

Procédé de purification d'un anticorps ou d'un fragment d'anticorps de celui-ci à l'aide d'une chromatographie d'affinité Download PDF

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Publication number
WO2018212556A1
WO2018212556A1 PCT/KR2018/005552 KR2018005552W WO2018212556A1 WO 2018212556 A1 WO2018212556 A1 WO 2018212556A1 KR 2018005552 W KR2018005552 W KR 2018005552W WO 2018212556 A1 WO2018212556 A1 WO 2018212556A1
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WO
WIPO (PCT)
Prior art keywords
buffer
antibody
antibody fragment
resin
elution buffer
Prior art date
Application number
PCT/KR2018/005552
Other languages
English (en)
Inventor
Kyunghwa Kim
Sung-Muk KANG
Jung Min Yoo
Hong Jai Lee
Se Jun Kim
Chung Min Lee
Yoo Hee Yang
Dong Eok Lee
Gyong-sik HA
Original Assignee
Cj Healthcare Corporation
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 Corporation filed Critical Cj Healthcare Corporation
Priority claimed from KR1020180055313A external-priority patent/KR102087823B1/ko
Publication of WO2018212556A1 publication Critical patent/WO2018212556A1/fr

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    • 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
    • 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 - B01D15/36
    • B01D15/3804—Affinity 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
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55—Fab or Fab'

Definitions

  • the antibody may specifically be a monoclonal antibody.
  • the term "monoclonal antibody” refers to an antibody which can be formed by a cell with an antibody-encoding sequence and which recognizes a specific antigen.
  • the antibody of the present disclosure although not limited thereto, may preferably include all therapeutic antibodies conventionally used in the art.
  • the purity of the target antibody or antibody fragment thereof can be measured by HPLC analysis after purification from the elution buffer, and specifically can be analyzed by CEX-HPLC, but is not limited thereto.
  • Fig. 7b shows the results of CEX-HPLC analysis of the substance separated using the elution buffer when the light chain affinity resin was used, confirming that the substance separated from the elution buffer had a purity of 53% or higher.
  • Comparative Example 1 Setting purification condition for antibody fragment (using light chain affinity resin)

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

Abstract

La présente invention concerne un procédé de séparation et de purification d'un anticorps ou d'un fragment d'anticorps de celui-ci avec une pureté élevée à l'aide d'une chromatographie d'affinité, et particulièrement, un procédé de séparation d'anticorps et d'un fragment de celui-ci avec une pureté élevée ainsi qu'un procédé de purification dudit anticorps à l'aide d'un tampon d'élution capable d'augmenter la stabilité afin d'améliorer cette dernière.
PCT/KR2018/005552 2017-05-16 2018-05-15 Procédé de purification d'un anticorps ou d'un fragment d'anticorps de celui-ci à l'aide d'une chromatographie d'affinité WO2018212556A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
KR10-2017-0060535 2017-05-16
KR20170060535 2017-05-16
KR1020180055313A KR102087823B1 (ko) 2017-05-16 2018-05-15 친화성 크로마토그래피를 이용한 항체 또는 항체절편 정제 방법
KR10-2018-0055313 2018-05-15

Publications (1)

Publication Number Publication Date
WO2018212556A1 true WO2018212556A1 (fr) 2018-11-22

Family

ID=64274362

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2018/005552 WO2018212556A1 (fr) 2017-05-16 2018-05-15 Procédé de purification d'un anticorps ou d'un fragment d'anticorps de celui-ci à l'aide d'une chromatographie d'affinité

Country Status (1)

Country Link
WO (1) WO2018212556A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110204612A (zh) * 2019-05-29 2019-09-06 上海药明生物技术有限公司 采用Protein A亲和层析纯化纳米抗体药物的方法

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140051833A1 (en) * 2012-03-13 2014-02-20 Novlmmune S.A. Readily Isolated Bispecific Antibodies with Native Immunoglobulin Format
US20140094593A1 (en) * 2011-06-01 2014-04-03 Novartis Ag Purification method for proteins, in particular antibodies, utilizing a wash solution comprising arginine at high pH for the affinity chromatography step
US20160130366A1 (en) * 2014-10-01 2016-05-12 Medimmune Limited Antibodies to ticagrelor and methods of use
WO2016075034A1 (fr) * 2014-11-10 2016-05-19 F. Hoffmann-La Roche Ag Anticorps anti-il-1bêta et leurs méthodes d'utilisation
US20160159917A1 (en) * 2013-05-07 2016-06-09 Hoffmann-La Roche Inc. Trimeric antigen binding molecules

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140094593A1 (en) * 2011-06-01 2014-04-03 Novartis Ag Purification method for proteins, in particular antibodies, utilizing a wash solution comprising arginine at high pH for the affinity chromatography step
US20140051833A1 (en) * 2012-03-13 2014-02-20 Novlmmune S.A. Readily Isolated Bispecific Antibodies with Native Immunoglobulin Format
US20160159917A1 (en) * 2013-05-07 2016-06-09 Hoffmann-La Roche Inc. Trimeric antigen binding molecules
US20160130366A1 (en) * 2014-10-01 2016-05-12 Medimmune Limited Antibodies to ticagrelor and methods of use
WO2016075034A1 (fr) * 2014-11-10 2016-05-19 F. Hoffmann-La Roche Ag Anticorps anti-il-1bêta et leurs méthodes d'utilisation

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110204612A (zh) * 2019-05-29 2019-09-06 上海药明生物技术有限公司 采用Protein A亲和层析纯化纳米抗体药物的方法

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