AU2017298984B2 - Methods of purifying Fc-containing proteins - Google Patents

Methods of purifying Fc-containing proteins Download PDF

Info

Publication number
AU2017298984B2
AU2017298984B2 AU2017298984A AU2017298984A AU2017298984B2 AU 2017298984 B2 AU2017298984 B2 AU 2017298984B2 AU 2017298984 A AU2017298984 A AU 2017298984A AU 2017298984 A AU2017298984 A AU 2017298984A AU 2017298984 B2 AU2017298984 B2 AU 2017298984B2
Authority
AU
Australia
Prior art keywords
protein
temperature
elution buffer
region
amino acid
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
AU2017298984A
Other languages
English (en)
Other versions
AU2017298984A1 (en
Inventor
John K. KAWOOYA
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.)
Amgen Inc
Original Assignee
Amgen Inc
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 Amgen Inc filed Critical Amgen Inc
Publication of AU2017298984A1 publication Critical patent/AU2017298984A1/en
Application granted granted Critical
Priority to AU2023222915A priority Critical patent/AU2023222915A1/en
Publication of AU2017298984B2 publication Critical patent/AU2017298984B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • 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
    • 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
    • C07K1/34—Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis
    • 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
    • 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)

Landscapes

  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Molecular Biology (AREA)
  • Medicinal Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • General Health & Medical Sciences (AREA)
  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (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)
AU2017298984A 2016-07-22 2017-07-21 Methods of purifying Fc-containing proteins Active AU2017298984B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2023222915A AU2023222915A1 (en) 2016-07-22 2023-08-31 Methods of purifying Fc-containing proteins

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)

Application Number Title Priority Date Filing Date
AU2023222915A Division AU2023222915A1 (en) 2016-07-22 2023-08-31 Methods of purifying Fc-containing proteins

Publications (2)

Publication Number Publication Date
AU2017298984A1 AU2017298984A1 (en) 2019-02-07
AU2017298984B2 true AU2017298984B2 (en) 2023-08-31

Family

ID=59656168

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2017298984A Active AU2017298984B2 (en) 2016-07-22 2017-07-21 Methods of purifying Fc-containing proteins
AU2023222915A Pending AU2023222915A1 (en) 2016-07-22 2023-08-31 Methods of purifying Fc-containing proteins

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2023222915A Pending AU2023222915A1 (en) 2016-07-22 2023-08-31 Methods of purifying Fc-containing proteins

Country Status (12)

Country Link
US (1) US11312745B2 (cg-RX-API-DMAC7.html)
EP (1) EP3487867A2 (cg-RX-API-DMAC7.html)
JP (2) JP7092744B2 (cg-RX-API-DMAC7.html)
KR (2) KR102435801B1 (cg-RX-API-DMAC7.html)
CN (2) CN109563125B (cg-RX-API-DMAC7.html)
AU (2) AU2017298984B2 (cg-RX-API-DMAC7.html)
CA (2) CA3031469C (cg-RX-API-DMAC7.html)
IL (2) IL285146B (cg-RX-API-DMAC7.html)
MA (1) MA45721A (cg-RX-API-DMAC7.html)
MX (2) MX2019000903A (cg-RX-API-DMAC7.html)
SG (1) SG11201900573UA (cg-RX-API-DMAC7.html)
WO (1) WO2018018011A2 (cg-RX-API-DMAC7.html)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2019343053A1 (en) * 2018-09-21 2021-04-15 Teneobio, Inc. Methods for purifying heterodimeric, multispecific antibodies
WO2020077212A1 (en) * 2018-10-11 2020-04-16 Amgen Inc. Downstream processing of bispecific antibody constructs
CN113227785A (zh) * 2019-01-16 2021-08-06 瑞泽恩制药公司 识别和定量抗体片段化的方法和系统
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
EP4132656A1 (en) 2020-04-09 2023-02-15 CytomX Therapeutics, Inc. Compositions containing activatable antibodies
EP4213958A1 (en) * 2020-09-16 2023-07-26 Waters Technologies Corporation Improved size exclusion chromatography utilizing low concentration amino acids in size exclusion chromatography mobile phase
CN118414350A (zh) * 2021-10-19 2024-07-30 阿特根公司 纯化具有igg fc结构域的融合蛋白的方法
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 (1)

* 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

Family Cites Families (44)

* 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
DE69133566T2 (de) 1990-01-12 2007-12-06 Amgen Fremont Inc. Bildung von xenogenen Antikörpern
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
US5350683A (en) 1990-06-05 1994-09-27 Immunex Corporation DNA encoding type II interleukin-1 receptors
AU651596B2 (en) 1990-06-05 1994-07-28 Immunex Corporation Type II interleukin-1 receptors
GB9015198D0 (en) 1990-07-10 1990-08-29 Brien Caroline J O Binding substance
US5874299A (en) 1990-08-29 1999-02-23 Genpharm International, Inc. Transgenic non-human animals capable of 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
US5545806A (en) 1990-08-29 1996-08-13 Genpharm International, Inc. Ransgenic non-human animals for producing heterologous antibodies
US6255458B1 (en) 1990-08-29 2001-07-03 Genpharm International High affinity human antibodies and human antibodies against digoxin
US6300129B1 (en) 1990-08-29 2001-10-09 Genpharm International Transgenic non-human animals for producing heterologous antibodies
WO1992003918A1 (en) 1990-08-29 1992-03-19 Genpharm International, Inc. Transgenic non-human animals capable of producing heterologous antibodies
NZ255101A (en) 1992-07-24 1997-08-22 Cell Genesys Inc A yeast artificial chromosome (yac) vector containing an hprt minigene expressible in murine stem cells and genetically modified rodent therefor
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
ATE390933T1 (de) 1995-04-27 2008-04-15 Amgen Fremont Inc Aus immunisierten xenomäusen stammende menschliche antikörper gegen il-8
CA2722378C (en) 1996-12-03 2015-02-03 Amgen Fremont Inc. Human antibodies that bind tnf.alpha.
US6271349B1 (en) 1996-12-23 2001-08-07 Immunex Corporation Receptor activator of NF-κB
WO1999053059A1 (en) * 1998-04-16 1999-10-21 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
CN101213211A (zh) * 2005-06-17 2008-07-02 惠氏公司 纯化含Fc区蛋白的方法
US7834162B2 (en) * 2006-01-06 2010-11-16 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
US10982250B2 (en) * 2006-09-18 2021-04-20 Genentech, Inc. Methods of protein production
PT2235064E (pt) 2008-01-07 2016-03-01 Amgen Inc Método de preparação de moléculas heterodiméricas de fc de anticorpos utilizando efeitos de indução eletrostática
MX2011001696A (es) * 2008-08-14 2011-03-25 Merck Sharp & Dohme Metodos para purificar anticuerpos usando cromatografia de afinidad con proteina a.
EP2445923B1 (en) * 2009-06-22 2018-09-05 Amgen, Inc Refolding proteins using a chemically controlled redox state
MX2011013417A (es) 2009-06-25 2012-03-29 Amgen Inc Procesos de purificacion por captura para proteinas expresadas en un sistema no mamifero.
JP6091894B2 (ja) 2009-09-16 2017-03-15 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
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
EP2657254A4 (en) 2010-12-24 2014-01-08 Asahi Kasei Medical Co Ltd PROCESS FOR IMMOBILIZING THE TEMPERATURE-REACTIVE PROTEIN A
DK2729482T3 (en) * 2011-07-08 2018-05-07 Merck Sharp & Dohme PROCEDURE FOR CLEANING FC-FUSION PROTEIN
JP6420756B2 (ja) * 2012-03-28 2018-11-07 ジーイー・ヘルスケア・バイオプロセス・アールアンドディ・アクチボラグ アフィニティークロマトグラフィーマトリックス
WO2014034644A1 (ja) 2012-08-27 2014-03-06 旭化成メディカル株式会社 温度応答性クロマトグラフィーによる抗体の精製方法
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
EP3176185A1 (en) * 2013-11-04 2017-06-07 Glenmark Pharmaceuticals S.A. Production of t cell retargeting hetero-dimeric immunoglobulins

Patent Citations (1)

* 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

Also Published As

Publication number Publication date
AU2017298984A1 (en) 2019-02-07
CN115925780A (zh) 2023-04-07
SG11201900573UA (en) 2019-02-27
CN109563125B (zh) 2022-08-09
JP2022120138A (ja) 2022-08-17
EP3487867A2 (en) 2019-05-29
KR20220120716A (ko) 2022-08-30
WO2018018011A3 (en) 2018-03-01
CN109563125A (zh) 2019-04-02
IL285146B (en) 2022-09-01
IL264375B (en) 2021-09-30
WO2018018011A2 (en) 2018-01-25
JP7411020B2 (ja) 2024-01-10
KR102579850B1 (ko) 2023-09-18
IL264375A (en) 2019-02-28
CA3031469C (en) 2025-11-18
AU2023222915A1 (en) 2023-09-21
US11312745B2 (en) 2022-04-26
CN115925780B (zh) 2025-11-04
CA3031469A1 (en) 2018-01-25
MX2019000903A (es) 2019-05-15
MX2023006291A (es) 2023-06-13
JP7092744B2 (ja) 2022-06-28
MA45721A (fr) 2019-05-29
US20190127418A1 (en) 2019-05-02
KR102435801B1 (ko) 2022-08-25
KR20190037247A (ko) 2019-04-05
IL285146A (en) 2021-08-31
CA3218290A1 (en) 2018-01-25
JP2019528255A (ja) 2019-10-10

Similar Documents

Publication Publication Date Title
AU2017298984B2 (en) Methods of purifying Fc-containing proteins
US9334319B2 (en) Low acidic species compositions
US9708400B2 (en) Methods to modulate lysine variant distribution
US20160115193A1 (en) Novel purification of antibodies using hydrophobic interaction chromatography
CA2805132C (en) Purification of antibody fragments
US20130336957A1 (en) Novel purification of human, humanized, or chimeric antibodies using protein a affinity chromatography
WO2012125735A1 (en) An integrated approach to the isolation and purification of antibodies
AU2018326458B2 (en) Method for purifying proteins
US11964998B2 (en) Method for purifying anti-IL-6 receptor antibodies

Legal Events

Date Code Title Description
FGA Letters patent sealed or granted (standard patent)