CA3031469C - PROCESSES FOR PURIFYING PROTEINS CONTAINING FC FRAGMENTS - Google Patents

PROCESSES FOR PURIFYING PROTEINS CONTAINING FC FRAGMENTS

Info

Publication number
CA3031469C
CA3031469C CA3031469A CA3031469A CA3031469C CA 3031469 C CA3031469 C CA 3031469C CA 3031469 A CA3031469 A CA 3031469A CA 3031469 A CA3031469 A CA 3031469A CA 3031469 C CA3031469 C CA 3031469C
Authority
CA
Canada
Prior art keywords
protein
temperature
region
amino acid
elution buffer
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
CA3031469A
Other languages
English (en)
French (fr)
Other versions
CA3031469A1 (en
Inventor
John K. KAWOOYA
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
Priority to CA3218290A priority Critical patent/CA3218290A1/en
Publication of CA3031469A1 publication Critical patent/CA3031469A1/en
Application granted granted Critical
Publication of CA3031469C publication Critical patent/CA3031469C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/26Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/34Size-selective separation, e.g. size-exclusion chromatography; Gel filtration; Permeation
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/26Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/38Selective 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
    • B01D15/3804Affinity chromatography
    • B01D15/3809Affinity chromatography of the antigen-antibody type, e.g. protein A, G or L chromatography
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/42Selective adsorption, e.g. chromatography characterised by the development mode, e.g. by displacement or by elution
    • B01D15/424Elution mode
    • B01D15/426Specific type of solvent
    • 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
    • C07K1/34Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • 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
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/35Valency
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/60Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/60Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/62Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/622Single chain antibody (scFv)

Landscapes

  • 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)
CA3031469A 2016-07-22 2017-07-21 PROCESSES FOR PURIFYING PROTEINS CONTAINING FC FRAGMENTS Active CA3031469C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA3218290A CA3218290A1 (en) 2016-07-22 2017-07-21 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
CA3218290A Division CA3218290A1 (en) 2016-07-22 2017-07-21 Methods of purifying fc-containing proteins

Publications (2)

Publication Number Publication Date
CA3031469A1 CA3031469A1 (en) 2018-01-25
CA3031469C true CA3031469C (en) 2025-11-18

Family

ID=59656168

Family Applications (2)

Application Number Title Priority Date Filing Date
CA3031469A Active CA3031469C (en) 2016-07-22 2017-07-21 PROCESSES FOR PURIFYING PROTEINS CONTAINING FC FRAGMENTS
CA3218290A Pending CA3218290A1 (en) 2016-07-22 2017-07-21 Methods of purifying fc-containing proteins

Family Applications After (1)

Application Number Title Priority Date Filing Date
CA3218290A Pending CA3218290A1 (en) 2016-07-22 2017-07-21 Methods of purifying fc-containing proteins

Country Status (12)

Country Link
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

Family Cites Families (45)

* 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
JP5522723B2 (ja) * 2007-05-21 2014-06-18 ノマディックバイオサイエンス株式会社 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
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
SI3660032T1 (sl) * 2009-06-25 2026-02-27 Amgen Inc. Postopki zajemanja in čiščenja beljakovin, izraženih v nesesalskem sistemu
MX2012003396A (es) 2009-09-16 2012-04-10 Genentech Inc Complejos de proteina conteniendo helice super-enrollada y/o enlazador tether y usos de los mismos.
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

Also Published As

Publication number Publication date
JP7411020B2 (ja) 2024-01-10
EP3487867A2 (en) 2019-05-29
CA3218290A1 (en) 2018-01-25
IL264375A (en) 2019-02-28
KR102435801B1 (ko) 2022-08-25
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

Similar Documents

Publication Publication Date Title
AU2023222915B2 (en) Methods of purifying Fc-containing proteins
US9957318B2 (en) Protein purification methods to reduce acidic species
US20160115193A1 (en) Novel purification of antibodies using hydrophobic interaction chromatography
US20130336957A1 (en) Novel purification of human, humanized, or chimeric antibodies using protein a affinity chromatography
AU2018326458B2 (en) Method for purifying proteins
WO2012125735A1 (en) An integrated approach to the isolation and purification of antibodies
US20150110803A1 (en) Low acidic species compositions and methods for producing and using the same using displacement chromatography
US11964998B2 (en) Method for purifying anti-IL-6 receptor antibodies
HK40034198B (en) Method for purifying anti-il-6 receptor antibodies
HK40034198A (en) Method for purifying anti-il-6 receptor antibodies

Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20220421

D22 Grant of ip right intended

Free format text: ST27 STATUS EVENT CODE: A-2-2-D10-D22-D128 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: NOTICE OF ALLOWANCE IS ISSUED

Effective date: 20250530

Free format text: ST27 STATUS EVENT CODE: A-2-2-D10-D22-D128 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: ALLOWANCE REQUIREMENTS DETERMINED COMPLIANT

Effective date: 20250530

W00 Other event occurred

Free format text: ST27 STATUS EVENT CODE: A-2-2-W10-W00-W100 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: LETTER SENT

Effective date: 20250530

MFA Maintenance fee for application paid

Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 8TH ANNIV.) - STANDARD

Year of fee payment: 8

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-4-4-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20250625

D00 Search and/or examination requested or commenced

Free format text: ST27 STATUS EVENT CODE: A-2-2-D10-D00-D164 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: RESPONSE TO NOTICE OF ALLOWANCE

Effective date: 20250806

D22 Grant of ip right intended

Free format text: ST27 STATUS EVENT CODE: A-2-4-D10-D22-D143 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: PRE-GRANT

Effective date: 20250826

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: 20250826

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-4-4-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20251014

Q17 Modified document published

Free format text: ST27 STATUS EVENT CODE: A-4-4-Q10-Q17-Q103 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: DOCUMENT PUBLISHED

Effective date: 20251117

F11 Ip right granted following substantive examination

Free format text: ST27 STATUS EVENT CODE: A-4-4-F10-F11-X000 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: GRANT BY ISSUANCE

Effective date: 20251118