JP7753105B2 - 抗体の精製方法及びその組成物 - Google Patents

抗体の精製方法及びその組成物

Info

Publication number
JP7753105B2
JP7753105B2 JP2021573301A JP2021573301A JP7753105B2 JP 7753105 B2 JP7753105 B2 JP 7753105B2 JP 2021573301 A JP2021573301 A JP 2021573301A JP 2021573301 A JP2021573301 A JP 2021573301A JP 7753105 B2 JP7753105 B2 JP 7753105B2
Authority
JP
Japan
Prior art keywords
antibody
less
resin
elution
protein
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.)
Active
Application number
JP2021573301A
Other languages
English (en)
Japanese (ja)
Other versions
JP2022536659A (ja
JP2022536659A5 (https=
Inventor
エフ. オッペンハイム,シェルダン
パークス,ジョージ
シュールク,ノーバート
カート,ラトフィエ
イー. ドーラン,マイケル
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.)
Takeda Pharmaceutical Co Ltd
Original Assignee
Takeda Pharmaceutical Co Ltd
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 Takeda Pharmaceutical Co Ltd filed Critical Takeda Pharmaceutical Co Ltd
Publication of JP2022536659A publication Critical patent/JP2022536659A/ja
Publication of JP2022536659A5 publication Critical patent/JP2022536659A5/ja
Priority to JP2025022330A priority Critical patent/JP2025087720A/ja
Application granted granted Critical
Publication of JP7753105B2 publication Critical patent/JP7753105B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • C07K1/04General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length on carriers
    • 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
    • C07K1/145Extraction; Separation; Purification by extraction or solubilisation
    • 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
    • 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
    • C07K1/165Extraction; Separation; Purification by chromatography mixed-mode chromatography
    • 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
    • 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
    • C07K1/20Partition-, reverse-phase or hydrophobic interaction chromatography
    • 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
    • C07K1/22Affinity chromatography or related techniques based upon selective absorption processes
    • 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
    • C07K1/36Extraction; Separation; Purification by a combination of two or more processes of different types
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/005Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies constructed by phage libraries
    • 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
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2839Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity determining region [CDR]

Landscapes

  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Analytical Chemistry (AREA)
  • Immunology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Virology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
JP2021573301A 2019-06-10 2020-06-10 抗体の精製方法及びその組成物 Active JP7753105B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2025022330A JP2025087720A (ja) 2019-06-10 2025-02-14 抗体の精製方法及びその組成物

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962859580P 2019-06-10 2019-06-10
US62/859,580 2019-06-10
PCT/US2020/037069 WO2020252072A1 (en) 2019-06-10 2020-06-10 Antibody purification methods and compositions thereof

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2025022330A Division JP2025087720A (ja) 2019-06-10 2025-02-14 抗体の精製方法及びその組成物

Publications (3)

Publication Number Publication Date
JP2022536659A JP2022536659A (ja) 2022-08-18
JP2022536659A5 JP2022536659A5 (https=) 2024-02-08
JP7753105B2 true JP7753105B2 (ja) 2025-10-14

Family

ID=73782230

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2021573301A Active JP7753105B2 (ja) 2019-06-10 2020-06-10 抗体の精製方法及びその組成物
JP2025022330A Pending JP2025087720A (ja) 2019-06-10 2025-02-14 抗体の精製方法及びその組成物

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2025022330A Pending JP2025087720A (ja) 2019-06-10 2025-02-14 抗体の精製方法及びその組成物

Country Status (14)

Country Link
US (1) US20220259291A1 (https=)
EP (1) EP3980119A4 (https=)
JP (2) JP7753105B2 (https=)
CN (4) CN114025843B (https=)
AR (1) AR119268A1 (https=)
AU (1) AU2020290999A1 (https=)
BR (1) BR112021024848A2 (https=)
CA (1) CA3143169A1 (https=)
IL (1) IL288830A (https=)
MA (1) MA56132A (https=)
MX (1) MX2021015302A (https=)
PL (1) PL439807A1 (https=)
TW (1) TW202112800A (https=)
WO (1) WO2020252072A1 (https=)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019198099A1 (en) * 2018-04-10 2019-10-17 Dr. Reddy's Laboratories Limited Stable antibody formulation
EP4380948A4 (en) * 2021-08-05 2025-07-16 Dr Reddys Laboratories Ltd METHOD FOR PURIFYING AN ANTIBODY COMPOSITION BY MEANS OF CATION EXCHANGE CHROMATOGRAPHY
WO2023031965A1 (en) * 2021-09-03 2023-03-09 Dr. Reddy’S Laboratories Limited Method to obtain a purified antibody composition
WO2023180523A1 (en) * 2022-03-24 2023-09-28 Pieris Pharmaceuticals Gmbh Process for purifying fusion proteins
WO2024249568A1 (en) 2023-05-30 2024-12-05 Paragon Therapeutics, Inc. Alpha4beta7 integrin antibody compositions and methods of use
CN121889424A (zh) 2023-08-14 2026-04-17 派拉冈医疗公司 α4β7整联蛋白结合蛋白及使用方法

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014514346A (ja) 2011-05-02 2014-06-19 ミレニアム ファーマシューティカルズ, インコーポレイテッド 抗α4β7抗体のための製剤
US20170058019A1 (en) 2014-03-10 2017-03-02 Richter Gedeon Nyrt. Immunoglobulin purification using pre-cleaning steps

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7147851B1 (en) * 1996-08-15 2006-12-12 Millennium Pharmaceuticals, Inc. Humanized immunoglobulin reactive with α4β7 integrin
WO2006026759A2 (en) * 2004-09-03 2006-03-09 Genentech, Inc. Humanized anti-beta7 antagonists and uses therefor
MX367097B (es) * 2011-05-02 2019-08-05 Millennium Pharm Inc FORMULACION PARA ANTICUERPO ANTI-A4ß7.
JP6592426B2 (ja) * 2013-03-15 2019-10-16 バイオジェン・エムエイ・インコーポレイテッドBiogen MA Inc. 無塩条件下で疎水性相互作用クロマトグラフィーを使用するタンパク質精製
WO2018104893A1 (en) * 2016-12-06 2018-06-14 Glaxosmithkline Intellectual Property Development Limited Alpha4-beta7 antibodies with incrased fcrn binding and/or half-life

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014514346A (ja) 2011-05-02 2014-06-19 ミレニアム ファーマシューティカルズ, インコーポレイテッド 抗α4β7抗体のための製剤
US20170058019A1 (en) 2014-03-10 2017-03-02 Richter Gedeon Nyrt. Immunoglobulin purification using pre-cleaning steps

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
Antibody Technology Journal ,2016年,6,17-32
Journal of chromatography ,2007年,848(1),28-39

Also Published As

Publication number Publication date
CN118909121A (zh) 2024-11-08
JP2022536659A (ja) 2022-08-18
AU2020290999A1 (en) 2022-02-03
CN118909120A (zh) 2024-11-08
CN118909119A (zh) 2024-11-08
CN114025843B (zh) 2026-01-09
AR119268A1 (es) 2021-12-09
CN114025843A (zh) 2022-02-08
EP3980119A4 (en) 2023-06-07
WO2020252072A1 (en) 2020-12-17
US20220259291A1 (en) 2022-08-18
PL439807A1 (pl) 2022-12-05
TW202112800A (zh) 2021-04-01
IL288830A (en) 2022-02-01
JP2025087720A (ja) 2025-06-10
EP3980119A1 (en) 2022-04-13
BR112021024848A2 (pt) 2022-01-18
CA3143169A1 (en) 2020-12-17
MA56132A (fr) 2022-04-13
MX2021015302A (es) 2022-01-18

Similar Documents

Publication Publication Date Title
JP7753105B2 (ja) 抗体の精製方法及びその組成物
US9249182B2 (en) Purification of antibodies using hydrophobic interaction chromatography
RU2553214C2 (ru) Способы очистки однодоменных антигенсвязывающих молекул
US20140288278A1 (en) Chromatography process for resolving heterogeneous antibody aggregates
US20120141497A1 (en) Methods of purifying small modular immunopharmaceutical proteins
US20130338344A1 (en) Protein purification methods to reduce acidic species
JP7624414B2 (ja) 抗α4β7抗体の産生方法
JP2019525925A (ja) アフィニティークロマトグラフィー洗浄バッファー
AU2018392697A1 (en) Methods for enhanced removal of impurities during protein a chromatography
JP2016504337A (ja) イオン交換クロマトグラフィーを使用して高マンノースグリコフォームのレベルを制御する方法
US20250129117A1 (en) Rapid purification of monoclonal antibody from in-process upstream cell culture material
RU2852606C2 (ru) СПОСОБЫ ПОЛУЧЕНИЯ АНТИТЕЛА ПРОТИВ α4β7
BR122024018491A2 (pt) Métodos de purificação de anticorpos e composições dos mesmos
AU2024362809A1 (en) Rapid purification of monoclonal antibody from in-process upstream cell culture material

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20230609

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20230609

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20240131

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20240528

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20240709

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20240927

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20241015

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20241211

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20250214

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20250318

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20250618

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20250902

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20251001

R150 Certificate of patent or registration of utility model

Ref document number: 7753105

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150