CA3143169A1 - Antibody purification methods and compositions thereof - Google Patents

Antibody purification methods and compositions thereof Download PDF

Info

Publication number
CA3143169A1
CA3143169A1 CA3143169A CA3143169A CA3143169A1 CA 3143169 A1 CA3143169 A1 CA 3143169A1 CA 3143169 A CA3143169 A CA 3143169A CA 3143169 A CA3143169 A CA 3143169A CA 3143169 A1 CA3143169 A1 CA 3143169A1
Authority
CA
Canada
Prior art keywords
antibody
resin
solution
seq
composition
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
CA3143169A
Other languages
English (en)
French (fr)
Inventor
George PARKS
Norbert Schuelke
Michael E. DOLAN
Sheldon F. Oppenheim
Lutfiye KURT
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 CA3143169A1 publication Critical patent/CA3143169A1/en
Pending legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • 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)
CA3143169A 2019-06-10 2020-06-10 Antibody purification methods and compositions thereof Pending CA3143169A1 (en)

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

Publications (1)

Publication Number Publication Date
CA3143169A1 true CA3143169A1 (en) 2020-12-17

Family

ID=73782230

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3143169A Pending CA3143169A1 (en) 2019-06-10 2020-06-10 Antibody purification methods and compositions thereof

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

Family Cites Families (7)

* 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
UA116189C2 (uk) 2011-05-02 2018-02-26 Мілленніум Фармасьютікалз, Інк. КОМПОЗИЦІЯ АНТИ-α4β7 АНТИТІЛА
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
PL3116891T3 (pl) * 2014-03-10 2020-07-27 Richter Gedeon Nyrt. Oczyszczanie immunoglobuliny z zastosowaniem etapów wstępnego oczyszczania
WO2018104893A1 (en) * 2016-12-06 2018-06-14 Glaxosmithkline Intellectual Property Development Limited Alpha4-beta7 antibodies with incrased fcrn binding and/or half-life

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
JP7753105B2 (ja) 2025-10-14
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
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
RU2553214C2 (ru) Способы очистки однодоменных антигенсвязывающих молекул
US20120141497A1 (en) Methods of purifying small modular immunopharmaceutical proteins
US20140288278A1 (en) Chromatography process for resolving heterogeneous antibody aggregates
MX2013014032A (es) Solucion y metodo de lavado para cromatografia de afinidad.
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
WO2013158279A1 (en) Protein purification methods to reduce acidic species
TWI853823B (zh) 自混合物製備多肽之系統及方法
CA3143167A1 (en) Methods of producing an anti-.alpha.4.beta.7 antibody
CN111712510A (zh) 用于在蛋白a色谱法期间增强杂质去除的方法
WO2020172658A1 (en) Methods of isolating a protein
Capela et al. Monoclonal Antibodies Addressing the Challenges on the Manufacturing Processing of an Advanced Class of Therapeutic Agents
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
BR122024018491A2 (pt) Métodos de purificação de anticorpos e composições dos mesmos
US20250129117A1 (en) Rapid purification of monoclonal antibody from in-process upstream cell culture material
RU2852606C2 (ru) СПОСОБЫ ПОЛУЧЕНИЯ АНТИТЕЛА ПРОТИВ α4β7
AU2024362809A1 (en) Rapid purification of monoclonal antibody from in-process upstream cell culture material

Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20220916

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: 20250224

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: 20250523

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: 20250523

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: 20250624

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: 20250703

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: 20250723

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: 20250723