JP2019521986A - 多重特異性抗体の精製 - Google Patents

多重特異性抗体の精製 Download PDF

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Publication number
JP2019521986A
JP2019521986A JP2018565786A JP2018565786A JP2019521986A JP 2019521986 A JP2019521986 A JP 2019521986A JP 2018565786 A JP2018565786 A JP 2018565786A JP 2018565786 A JP2018565786 A JP 2018565786A JP 2019521986 A JP2019521986 A JP 2019521986A
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JP
Japan
Prior art keywords
chromatography
antibody
mixed mode
anion exchange
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
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JP2018565786A
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English (en)
Japanese (ja)
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JP2019521986A5 (enExample
Inventor
グレン スコット ギース，
グレン スコット ギース，
エーファ ローゼンベルガー，
エーファ ローゼンベルガー，
ベルナール サリエル，
ベルナール サリエル，
ズザンネ コンラート，
ズザンネ コンラート，
ヴォルフガング ケーンライン，
ヴォルフガング ケーンライン，
シュテッフェン ヴィルマン，
シュテッフェン ヴィルマン，
アガーテ ビアラス，
アガーテ ビアラス，
キンバリー アン カレアス−キャロル，
キンバリー アン カレアス−キャロル，
インゲス イグゾー，
インゲス イグゾー，
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.)
Genentech Inc
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Genentech Inc
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Publication date
Application filed by Genentech Inc filed Critical Genentech Inc
Publication of JP2019521986A publication Critical patent/JP2019521986A/ja
Publication of JP2019521986A5 publication Critical patent/JP2019521986A5/ja
Priority to JP2022117433A priority Critical patent/JP7564843B2/ja
Priority to JP2024102664A priority patent/JP2024156655A/ja
Pending legal-status Critical Current

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065—Purification, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • 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
    • C07K1/165—Extraction; Separation; Purification by chromatography mixed-mode 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
    • C07K1/18—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 [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/22—Immunoglobulins [IG], 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
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/26—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against hormones ; against hormone releasing or inhibiting factors
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/46—Hybrid immunoglobulins
    • C07K16/468—Immunoglobulins having two or more different antigen binding sites, e.g. multifunctional antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • 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
    • C07K2317/526—CH3 domain
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/54—F(ab')2
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding

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  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Analytical Chemistry (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Ophthalmology & Optometry (AREA)
  • Water Supply & Treatment (AREA)
  • Endocrinology (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)
  • Medicinal Preparation (AREA)
JP2018565786A 2016-06-17 2017-06-16 多重特異性抗体の精製 Pending JP2019521986A (ja)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2022117433A JP7564843B2 (ja) 2016-06-17 2022-07-22 多重特異性抗体の精製
JP2024102664A JP2024156655A (ja) 2016-06-17 2024-06-26 多重特異性抗体の精製

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662351908P 2016-06-17 2016-06-17
US62/351,908 2016-06-17
PCT/US2017/038007 WO2017218977A2 (en) 2016-06-17 2017-06-16 Purification of multispecific antibodies

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2022117433A Division JP7564843B2 (ja) 2016-06-17 2022-07-22 多重特異性抗体の精製

Publications (2)

Publication Number Publication Date
JP2019521986A true JP2019521986A (ja) 2019-08-08
JP2019521986A5 JP2019521986A5 (enExample) 2020-08-06

Family

ID=59593150

Family Applications (3)

Application Number Title Priority Date Filing Date
JP2018565786A Pending JP2019521986A (ja) 2016-06-17 2017-06-16 多重特異性抗体の精製
JP2022117433A Active JP7564843B2 (ja) 2016-06-17 2022-07-22 多重特異性抗体の精製
JP2024102664A Pending JP2024156655A (ja) 2016-06-17 2024-06-26 多重特異性抗体の精製

Family Applications After (2)

Application Number Title Priority Date Filing Date
JP2022117433A Active JP7564843B2 (ja) 2016-06-17 2022-07-22 多重特異性抗体の精製
JP2024102664A Pending JP2024156655A (ja) 2016-06-17 2024-06-26 多重特異性抗体の精製

Country Status (18)

Country Link
US (1) US20190256556A1 (enExample)
EP (2) EP3472177B1 (enExample)
JP (3) JP2019521986A (enExample)
KR (3) KR20250107275A (enExample)
CN (1) CN109563124A (enExample)
AR (1) AR108800A1 (enExample)
AU (2) AU2017286676B2 (enExample)
BR (1) BR112018075516A2 (enExample)
CA (1) CA3026518A1 (enExample)
ES (1) ES2988363T3 (enExample)
HR (1) HRP20241323T1 (enExample)
HU (1) HUE068564T2 (enExample)
IL (1) IL263690B2 (enExample)
MX (2) MX2018015173A (enExample)
PL (1) PL3472177T3 (enExample)
SG (1) SG11201810777WA (enExample)
TW (1) TWI798179B (enExample)
WO (1) WO2017218977A2 (enExample)

Cited By (6)

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WO2022191158A1 (ja) * 2021-03-09 2022-09-15 Ｊｃｒファーマ株式会社 抗体－リソソーム酵素融合蛋白質の製造方法
WO2022225060A1 (ja) * 2021-04-23 2022-10-27 協和キリン株式会社 分解物の産生を抑制する方法
JP2023510382A (ja) * 2020-01-15 2023-03-13 エフ． ホフマン－ラ ロシュ アーゲー 組換えタンパク質製造プロセスから不純物を減少させる方法
JP2023542079A (ja) * 2020-09-21 2023-10-05 ジェネンテック， インコーポレイテッド 多重特異性抗体の精製
JP2024500747A (ja) * 2020-12-18 2024-01-10 キニクサ ファーマシューティカルズ， リミテッド タンパク質組成物ならびにそれを産生及び使用するための方法
JP2024539136A (ja) * 2021-10-19 2024-10-28 アルテオジェン・インコーポレイテッド ＩｇＧ Ｆｃドメインを有する融合タンパク質の精製方法

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EP3676280B1 (en) * 2017-08-30 2025-03-19 Fresenius Kabi Deutschland GmbH Method for purifying anti-il-6 receptor antibodies
CN111491951B (zh) * 2017-12-22 2024-05-24 豪夫迈·罗氏有限公司 通过疏水相互作用色谱法耗尽轻链错配的抗体变体
WO2019149693A1 (en) * 2018-01-30 2019-08-08 Univercells S.A. Protein purification process and platform
US20210040146A1 (en) * 2018-01-30 2021-02-11 Exothera S.A. Protein purification process
WO2019154776A1 (en) * 2018-02-06 2019-08-15 F. Hoffmann-La Roche Ag Treatment of ophthalmologic diseases
US12071476B2 (en) 2018-03-02 2024-08-27 Kodiak Sciences Inc. IL-6 antibodies and fusion constructs and conjugates thereof
US20230182041A1 (en) * 2018-04-25 2023-06-15 Medimmune, Llc Purification of antibodies
SG11202103064YA (en) 2018-10-29 2021-05-28 Hoffmann La Roche Antibody formulation
CN111423512B (zh) * 2019-01-10 2024-01-05 北京比洋生物技术有限公司 阻断血管内皮细胞生长且活化t细胞的多靶向融合蛋白和包含其的药物组合物
TWI871300B (zh) * 2019-01-28 2025-02-01 美商安進公司 藉由將藥物物質和藥物產品過程整體化的生物製劑製造之連續製造過程
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CN114026108B (zh) * 2019-06-28 2024-09-10 夏尔巴生物技术(苏州)有限公司 无缝连续流层析方法
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EP4061825A1 (en) * 2019-11-22 2022-09-28 MorphoSys AG Method to increase antibody yield during ion exchange chromatography
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CN115066258A (zh) * 2020-02-28 2022-09-16 上海药明生物技术有限公司 双特异性抗体的纯化
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CN115734969A (zh) * 2020-04-13 2023-03-03 上海药明生物技术有限公司 双特异性抗体的纯化
US20230143066A1 (en) * 2020-04-17 2023-05-11 Ono Pharmaceutical Co., Ltd. Method for removing color from drug substance of protein preparation
CN113563469A (zh) * 2020-04-28 2021-10-29 江苏中新医药有限公司 高回收率纯化阿达木单抗的方法
AU2021262609A1 (en) 2020-05-01 2022-12-22 Kashiv Biosciences, Llc An improved process of purification of protein
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EP4142905A4 (en) * 2020-05-01 2024-11-13 Kashiv Biosciences, LLC IMPROVED PROCESS FOR PURIFICATION OF PROTEIN
CN114014906B (zh) * 2020-06-24 2024-01-12 夏尔巴生物技术(苏州)有限公司 一种利用阳离子交换层析纯化疏水性蛋白的方法
CN114539416B (zh) * 2020-11-26 2024-11-08 盛禾(中国)生物制药有限公司 一种双特异性抗体的层析纯化工艺
ES3040791T3 (en) 2020-12-18 2025-11-05 Richter Gedeon Nyrt Methods for the purification of refolded fc-peptide fusion protein
TW202241924A (zh) * 2021-04-23 2022-11-01 大陸商和鉑醫藥（上海）有限責任公司 一種雙特異性抗體的純化方法
WO2022272119A2 (en) * 2021-06-25 2022-12-29 The Board Of Trustees Of The University Of Illinois Synthetic toolkit for plant transformation
WO2024076990A1 (en) * 2022-10-03 2024-04-11 Therini Bio, Inc. Multi-specific antigen binding proteins which bind human fibrin or fibrinogen ?c domain and vascular endothelial growth factor and methods of use
CN117990807B (zh) * 2022-11-07 2024-09-24 北京东方百泰生物科技股份有限公司 一种抗tslp单克隆抗体电荷异质性的检测方法
CN119264256B (zh) * 2023-07-07 2026-01-02 齐鲁制药有限公司 一种单克隆抗体的纯化方法
CN116769044A (zh) * 2023-07-11 2023-09-19 康日百奥生物科技(苏州)有限公司 抗cd3和cd19双特异性抗体蛋白及其层析纯化方法
WO2025029614A1 (en) * 2023-07-28 2025-02-06 Amgen Inc. A method for equilibrating a chromatography medium
WO2025088516A1 (en) * 2023-10-26 2025-05-01 Pfizer Inc. Method of forming multi-specific antibodies from homodimer antibodies and pharmaceutical product including multi-specific antibodies thus obtained
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