KR102435801B1 - Fc-함유 단백질의 정제 방법 - Google Patents

Fc-함유 단백질의 정제 방법 Download PDF

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KR102435801B1
KR102435801B1 KR1020197003162A KR20197003162A KR102435801B1 KR 102435801 B1 KR102435801 B1 KR 102435801B1 KR 1020197003162 A KR1020197003162 A KR 1020197003162A KR 20197003162 A KR20197003162 A KR 20197003162A KR 102435801 B1 KR102435801 B1 KR 102435801B1
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protein
temperature
elution buffer
antibody
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KR20190037247A (ko
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존 케이. 카우야
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암젠 인크
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • 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
    • B01D15/34—Size-selective separation, e.g. size-exclusion chromatography; Gel filtration; Permeation
    • 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 and B01D15/30 - B01D15/36, e.g. affinity, ligand exchange or chiral chromatography
    • B01D15/3804—Affinity chromatography
    • B01D15/3809—Affinity chromatography of the antigen-antibody type, e.g. protein A, G or L chromatography
    • 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
    • C07K1/22—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
    • 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
    • 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
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/35—Valency
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/62—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/622—Single chain antibody (scFv)

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  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Molecular Biology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Water Supply & Treatment (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Storage Device Security (AREA)
KR1020197003162A 2016-07-22 2017-07-21 Fc-함유 단백질의 정제 방법 Active KR102435801B1 (ko)

Priority Applications (1)

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KR1020227028721A KR102579850B1 (ko) 2016-07-22 2017-07-21 Fc-함유 단백질의 정제 방법

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662365943P 2016-07-22 2016-07-22
US62/365,943 2016-07-22
PCT/US2017/043384 WO2018018011A2 (en) 2016-07-22 2017-07-21 Methods of purifying fc-containing proteins

Related Child Applications (1)

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KR1020227028721A Division KR102579850B1 (ko) 2016-07-22 2017-07-21 Fc-함유 단백질의 정제 방법

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KR20190037247A KR20190037247A (ko) 2019-04-05
KR102435801B1 true KR102435801B1 (ko) 2022-08-25

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KR1020197003162A Active KR102435801B1 (ko) 2016-07-22 2017-07-21 Fc-함유 단백질의 정제 방법
KR1020227028721A Active KR102579850B1 (ko) 2016-07-22 2017-07-21 Fc-함유 단백질의 정제 방법

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US (1) US11312745B2 (enExample)
EP (1) EP3487867B1 (enExample)
JP (2) JP7092744B2 (enExample)
KR (2) KR102435801B1 (enExample)
CN (2) CN115925780B (enExample)
AU (2) AU2017298984B2 (enExample)
CA (2) CA3031469C (enExample)
IL (2) IL285146B (enExample)
MA (1) MA45721A (enExample)
MX (2) MX2019000903A (enExample)
SG (1) SG11201900573UA (enExample)
WO (1) WO2018018011A2 (enExample)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2019343053B2 (en) * 2018-09-21 2026-04-30 Teneobio, Inc. Methods for purifying heterodimeric, multispecific antibodies
AR117650A1 (es) * 2018-10-11 2021-08-18 Amgen Inc Procesamiento posterior de constructos de anticuerpos biespecíficos
BR112021011194A2 (pt) * 2019-01-16 2021-08-31 Regeneron Pharmaceuticals, Inc. Método e sistema de identificar e quantificar a fragmentação do anticorpo
KR102286892B1 (ko) 2019-07-08 2021-08-06 삼천당제약주식회사 안과용 단백질 제제의 정제방법
CN110724204B (zh) * 2019-11-18 2021-10-22 广东菲鹏制药股份有限公司 Fc融合蛋白的纯化方法
CN112881675A (zh) * 2019-11-29 2021-06-01 广东菲鹏生物有限公司 IgM抗体检测稀释液
CA3174665A1 (en) 2020-04-09 2021-10-14 Cytomx Therapeutics, Inc. Compositions containing activatable antibodies
CN116056775B (zh) * 2020-09-16 2025-12-02 沃特世科技公司 在尺寸排阻色谱流动相中使用低浓度氨基酸的改善尺寸排阻色谱法
WO2023068740A1 (ko) * 2021-10-19 2023-04-27 주식회사 알테오젠 Igg fc 도메인을 가지는 융합 단백질의 정제방법
CN113980092B (zh) * 2021-12-09 2024-05-14 上海药明生物技术有限公司 一种蛋白质亲和纯化方法
CN116165290B (zh) * 2021-12-17 2025-06-27 复旦大学 一种抗体药物研发流程中工程细胞株的筛选方法
CN116271982B (zh) * 2022-11-30 2024-01-09 杭州广科安德生物科技有限公司 一种血液高丰度蛋白免疫亲和柱的再生方法

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008143199A1 (ja) * 2007-05-21 2008-11-27 Nomadic Bioscience Co., Ltd. 新規ポリペプチド，アフィニティークロマトグラフィー用材，及びイムノグロブリンの分離及び／又は精製方法
JP2012531428A (ja) * 2009-06-25 2012-12-10 アムジエン・インコーポレーテツド 哺乳類以外の系で発現されるタンパク質の捕獲精製プロセス
JP2013505238A (ja) * 2009-09-16 2013-02-14 ジェネンテック， インコーポレイテッド コイルドコイルおよび／またはテザー含有タンパク質複合体およびその使用

Family Cites Families (42)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4968607A (en) 1987-11-25 1990-11-06 Immunex Corporation Interleukin-1 receptors
GB8823869D0 (en) 1988-10-12 1988-11-16 Medical Res Council Production of antibodies
WO1990005183A1 (en) 1988-10-31 1990-05-17 Immunex Corporation Interleukin-4 receptors
US5530101A (en) 1988-12-28 1996-06-25 Protein Design Labs, Inc. Humanized immunoglobulins
ES2284161T3 (es) 1990-01-12 2007-11-01 Amgen Fremont Inc. Generacion de anticuerpos xenogenicos.
US6673986B1 (en) 1990-01-12 2004-01-06 Abgenix, Inc. Generation of xenogeneic antibodies
US6713610B1 (en) 1990-01-12 2004-03-30 Raju Kucherlapati Human antibodies derived from immunized xenomice
US5427908A (en) 1990-05-01 1995-06-27 Affymax Technologies N.V. Recombinant library screening methods
WO1991018982A1 (en) 1990-06-05 1991-12-12 Immunex Corporation Type ii interleukin-1 receptors
US5350683A (en) 1990-06-05 1994-09-27 Immunex Corporation DNA encoding type II interleukin-1 receptors
GB9015198D0 (en) 1990-07-10 1990-08-29 Brien Caroline J O Binding substance
AU8507191A (en) 1990-08-29 1992-03-30 Genpharm International, Inc. Transgenic non-human animals capable of producing heterologous antibodies
US6300129B1 (en) 1990-08-29 2001-10-09 Genpharm International Transgenic non-human animals for producing heterologous antibodies
US5874299A (en) 1990-08-29 1999-02-23 Genpharm International, Inc. Transgenic non-human animals capable of producing heterologous antibodies
US5545806A (en) 1990-08-29 1996-08-13 Genpharm International, Inc. Ransgenic non-human animals for producing heterologous antibodies
US5877397A (en) 1990-08-29 1999-03-02 Genpharm International Inc. Transgenic non-human animals capable of producing heterologous antibodies of various isotypes
US6255458B1 (en) 1990-08-29 2001-07-03 Genpharm International High affinity human antibodies and human antibodies against digoxin
ES2301158T3 (es) 1992-07-24 2008-06-16 Amgen Fremont Inc. Produccion de anticuerpos xenogenicos.
US5731168A (en) 1995-03-01 1998-03-24 Genentech, Inc. Method for making heteromultimeric polypeptides
US6130364A (en) 1995-03-29 2000-10-10 Abgenix, Inc. Production of antibodies using Cre-mediated site-specific recombination
EP0822830B1 (en) 1995-04-27 2008-04-02 Amgen Fremont Inc. Human anti-IL-8 antibodies, derived from immunized xenomice
ATE549918T1 (de) 1996-12-03 2012-04-15 Amgen Fremont Inc Menschliche antikörper, die ausdrücklich menschliches tnf alpha binden
US6271349B1 (en) 1996-12-23 2001-08-07 Immunex Corporation Receptor activator of NF-κB
AU763513B2 (en) * 1998-04-16 2003-07-24 Genentech Inc. Secretion of glycosylated proteins using a tissue plasminogen activator pro-sequence
US6660843B1 (en) 1998-10-23 2003-12-09 Amgen Inc. Modified peptides as therapeutic agents
US20030133939A1 (en) 2001-01-17 2003-07-17 Genecraft, Inc. Binding domain-immunoglobulin fusion proteins
SG156672A1 (en) * 2004-10-22 2009-11-26 Amgen Inc Methods for refolding of recombinant antibodies
BRPI0611600B8 (pt) * 2005-06-17 2021-05-25 Wyeth Corp método para purificação de uma proteína tendo uma região fc a partir de um líquido fonte compreendendo a proteína e uma ou mais impurezas, e kit
CA2636109A1 (en) * 2006-01-06 2007-07-19 Amgen Inc. Methods and systems for isolating target molecules from complex solutions by column-chromatography using eluants containing organic solvents
CN105837690A (zh) 2006-06-12 2016-08-10 新兴产品开发西雅图有限公司 具有效应功能的单链多价结合蛋白
WO2008036600A2 (en) * 2006-09-18 2008-03-27 Genentech, Inc. Methods of protein production
EP3663318A1 (en) 2008-01-07 2020-06-10 Amgen Inc. Method for making antibody fc-heterodimeric molecules using electrostatic steering effects
WO2010019493A1 (en) * 2008-08-14 2010-02-18 Merck Sharp & Dohme Corp. Methods for purifying antibodies using protein a affinity chromatography
KR101741859B1 (ko) * 2009-06-22 2017-06-15 암젠 인크 화학적으로 조절된 산화환원 상태를 사용한 단백질의 재폴딩
CN102382190B (zh) * 2010-09-01 2014-04-09 山东新时代药业有限公司 分离和去除TNFR-Fc融合蛋白中寡聚体的方法
WO2012086837A1 (ja) 2010-12-24 2012-06-28 旭化成メディカル株式会社 温度応答性プロテインａの固定化方法
JP6280499B2 (ja) * 2011-07-08 2018-02-14 メルク・シャープ・アンド・ドーム・コーポレーションＭｅｒｃｋ Ｓｈａｒｐ ＆ Ｄｏｈｍｅ Ｃｏｒｐ． Ｆｃ融合タンパク質の精製方法
US10189891B2 (en) 2012-03-28 2019-01-29 Ge Healthcare Bioprocess R&D Ab Affinity chromatography matrix
EP2889617B1 (en) 2012-08-27 2017-10-11 Asahi Kasei Medical Co., Ltd. Antibody purification method by means of temperature-responsive chromatography
UY35148A (es) * 2012-11-21 2014-05-30 Amgen Inc Immunoglobulinas heterodiméricas
US20140302037A1 (en) 2013-03-15 2014-10-09 Amgen Inc. BISPECIFIC-Fc MOLECULES
WO2015063339A1 (en) * 2013-11-04 2015-05-07 Glenmark Pharmaceuticals S.A. Production of t cell retargeting hetero-dimeric immunoglobulins

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008143199A1 (ja) * 2007-05-21 2008-11-27 Nomadic Bioscience Co., Ltd. 新規ポリペプチド，アフィニティークロマトグラフィー用材，及びイムノグロブリンの分離及び／又は精製方法
JP2012531428A (ja) * 2009-06-25 2012-12-10 アムジエン・インコーポレーテツド 哺乳類以外の系で発現されるタンパク質の捕獲精製プロセス
JP2013505238A (ja) * 2009-09-16 2013-02-14 ジェネンテック， インコーポレイテッド コイルドコイルおよび／またはテザー含有タンパク質複合体およびその使用

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JP7411020B2 (ja) 2024-01-10
EP3487867A2 (en) 2019-05-29
CA3218290A1 (en) 2018-01-25
IL264375A (en) 2019-02-28
CA3031469C (en) 2025-11-18
CN109563125B (zh) 2022-08-09
EP3487867B1 (en) 2026-04-01
WO2018018011A2 (en) 2018-01-25
AU2023222915B2 (en) 2026-01-22
CN109563125A (zh) 2019-04-02
IL285146A (en) 2021-08-31
CN115925780B (zh) 2025-11-04
CA3031469A1 (en) 2018-01-25
US11312745B2 (en) 2022-04-26
AU2023222915A1 (en) 2023-09-21
AU2017298984A1 (en) 2019-02-07
WO2018018011A3 (en) 2018-03-01
KR20190037247A (ko) 2019-04-05
IL264375B (en) 2021-09-30
JP7092744B2 (ja) 2022-06-28
AU2017298984B2 (en) 2023-08-31
CN115925780A (zh) 2023-04-07
MX2023006291A (es) 2023-06-13
JP2019528255A (ja) 2019-10-10
MA45721A (fr) 2019-05-29
KR20220120716A (ko) 2022-08-30
IL285146B (en) 2022-09-01
KR102579850B1 (ko) 2023-09-18
JP2022120138A (ja) 2022-08-17
SG11201900573UA (en) 2019-02-27
US20190127418A1 (en) 2019-05-02
MX2019000903A (es) 2019-05-15

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