AU2016233557B2 - Use of alkaline washes during chromatography to remove impurities - Google Patents

Use of alkaline washes during chromatography to remove impurities Download PDF

Info

Publication number
AU2016233557B2
AU2016233557B2 AU2016233557A AU2016233557A AU2016233557B2 AU 2016233557 B2 AU2016233557 B2 AU 2016233557B2 AU 2016233557 A AU2016233557 A AU 2016233557A AU 2016233557 A AU2016233557 A AU 2016233557A AU 2016233557 B2 AU2016233557 B2 AU 2016233557B2
Authority
AU
Australia
Prior art keywords
chromatography
protein
interest
mab
wash solution
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
AU2016233557A
Other languages
English (en)
Other versions
AU2016233557A1 (en
Inventor
Neil E. JAFFE
Krina PATEL
Jue Wang
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.)
Bristol Myers Squibb Co
Original Assignee
Bristol Myers Squibb Co
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 Bristol Myers Squibb Co filed Critical Bristol Myers Squibb Co
Publication of AU2016233557A1 publication Critical patent/AU2016233557A1/en
Application granted granted Critical
Publication of AU2016233557B2 publication Critical patent/AU2016233557B2/en
Priority to AU2021221870A priority Critical patent/AU2021221870A1/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • B01D15/10—Selective adsorption, e.g. chromatography characterised by constructional or operational features
    • B01D15/20—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to the conditioning of the sorbent material
    • 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
    • B01D15/10—Selective adsorption, e.g. chromatography characterised by constructional or operational features
    • B01D15/18—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to flow patterns
    • B01D15/1864—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to flow patterns using two or more columns
    • B01D15/1871—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to flow patterns using two or more columns placed in series
    • 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
    • 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
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • 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
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N30/50—Conditioning of the sorbent material or stationary liquid
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N30/88—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
    • G01N2030/8809—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample
    • G01N2030/8813—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample biological materials
    • G01N2030/8831—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample biological materials involving peptides or proteins

Landscapes

  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Chemistry (AREA)
  • Pathology (AREA)
  • General Physics & Mathematics (AREA)
  • Physics & Mathematics (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Treatment Of Liquids With Adsorbents In General (AREA)
AU2016233557A 2015-03-13 2016-03-11 Use of alkaline washes during chromatography to remove impurities Active AU2016233557B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2021221870A AU2021221870A1 (en) 2015-03-13 2021-08-26 Use of alkaline washes during chromatography to remove impurities

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562132974P 2015-03-13 2015-03-13
US62/132,974 2015-03-13
PCT/US2016/021984 WO2016149088A1 (en) 2015-03-13 2016-03-11 Use of alkaline washes during chromatography to remove impurities

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2021221870A Division AU2021221870A1 (en) 2015-03-13 2021-08-26 Use of alkaline washes during chromatography to remove impurities

Publications (2)

Publication Number Publication Date
AU2016233557A1 AU2016233557A1 (en) 2017-11-02
AU2016233557B2 true AU2016233557B2 (en) 2021-06-24

Family

ID=55699796

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2016233557A Active AU2016233557B2 (en) 2015-03-13 2016-03-11 Use of alkaline washes during chromatography to remove impurities
AU2021221870A Abandoned AU2021221870A1 (en) 2015-03-13 2021-08-26 Use of alkaline washes during chromatography to remove impurities

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2021221870A Abandoned AU2021221870A1 (en) 2015-03-13 2021-08-26 Use of alkaline washes during chromatography to remove impurities

Country Status (13)

Country Link
US (2) US10695693B2 (enExample)
EP (2) EP4194071A1 (enExample)
JP (1) JP6807859B2 (enExample)
KR (1) KR102490956B1 (enExample)
CN (1) CN107636005B (enExample)
AU (2) AU2016233557B2 (enExample)
BR (1) BR112017018365A2 (enExample)
CA (1) CA2978095C (enExample)
EA (1) EA035635B1 (enExample)
IL (1) IL254372B (enExample)
MX (1) MX395730B (enExample)
SG (2) SG10201908027QA (enExample)
WO (1) WO2016149088A1 (enExample)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10738078B2 (en) * 2014-11-03 2020-08-11 Bristol-Myers Squibb Company Use of caprylic acid precipitation for protein purification
KR102490956B1 (ko) 2015-03-13 2023-01-19 브리스톨-마이어스 스큅 컴퍼니 불순물을 제거하기 위한 크로마토그래피 동안의 알칼리성 세척의 용도
CN110267721B (zh) 2017-01-30 2022-03-01 瑞泽恩制药公司 用于降低色谱中生物负载的组合物和方法
EP3810650A1 (en) * 2018-06-19 2021-04-28 Bristol-Myers Squibb Company Methods of purifying proteins using chromatography
CN112771379B (zh) * 2018-08-17 2024-07-02 瑞泽恩制药公司 用于测定多聚体蛋白质的量和纯度的方法和色谱系统
KR102270048B1 (ko) * 2020-07-10 2021-06-28 주식회사 녹십자 바리셀라 조스터 바이러스 표면 단백질 항원의 생산 방법
EP4270009A3 (en) * 2018-10-31 2024-01-17 Regeneron Pharmaceuticals, Inc. Method and system of identifying and quantifying a protein
CN113166200B (zh) * 2018-12-21 2024-03-01 上海药明生物技术有限公司 一种提高蛋白a层析法去除聚集体的方法
EA202191961A1 (ru) 2019-01-16 2021-12-13 Ридженерон Фармасьютикалз, Инк. Способ и система идентификации и количественного определения фрагментации антител
CN109870428A (zh) * 2019-01-21 2019-06-11 江苏华泰疫苗工程技术研究有限公司 一种基于表面等离子共振技术的抗体定量检测方法
GB201904741D0 (en) * 2019-04-04 2019-05-22 Glaxosmithkline Ip Dev Ltd Novel process
CN120334439A (zh) * 2019-09-24 2025-07-18 里珍纳龙药品有限公司 用于色谱介质的使用和再生的系统及方法
KR20220079844A (ko) * 2019-10-14 2022-06-14 피어스 바이오테크놀로지, 인크 펩티드 정제 제제 및 방법
CA3176109A1 (en) * 2020-03-27 2021-09-30 Haemalogix Pty Ltd Composition and method
WO2025178923A1 (en) * 2024-02-20 2025-08-28 Exelixis, Inc. Methods for protein purification

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0280578A2 (en) * 1987-02-26 1988-08-31 Dana-Farber Cancer Institute, Inc. Purification of LFA-3
US5190859A (en) * 1987-02-26 1993-03-02 Dana-Farber Cancer Institute, Inc. Purification of LFA-3
US6172197B1 (en) * 1991-07-10 2001-01-09 Medical Research Council Methods for producing members of specific binding pairs
WO2009058812A1 (en) * 2007-10-30 2009-05-07 Genentech, Inc. Antibody purification by cation exchange chromatography

Family Cites Families (48)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4816567A (en) 1983-04-08 1989-03-28 Genentech, Inc. Recombinant immunoglobin preparations
US5225539A (en) 1986-03-27 1993-07-06 Medical Research Council Recombinant altered antibodies and methods of making altered antibodies
CA1323567C (en) * 1987-10-05 1993-10-26 Gene R. Nathans Method for purification of antibodies
US5476996A (en) 1988-06-14 1995-12-19 Lidak Pharmaceuticals Human immune system in non-human animal
US5223409A (en) 1988-09-02 1993-06-29 Protein Engineering Corp. Directed evolution of novel binding proteins
GB8823869D0 (en) 1988-10-12 1988-11-16 Medical Res Council Production of antibodies
US5530101A (en) 1988-12-28 1996-06-25 Protein Design Labs, Inc. Humanized immunoglobulins
US6150584A (en) 1990-01-12 2000-11-21 Abgenix, Inc. Human antibodies derived from immunized xenomice
US6673986B1 (en) 1990-01-12 2004-01-06 Abgenix, Inc. Generation of xenogeneic antibodies
DE69133566T2 (de) 1990-01-12 2007-12-06 Amgen Fremont Inc. Bildung von xenogenen Antikörpern
US6075181A (en) 1990-01-12 2000-06-13 Abgenix, Inc. Human antibodies derived from immunized xenomice
US5427908A (en) 1990-05-01 1995-06-27 Affymax Technologies N.V. Recombinant library screening methods
GB9015198D0 (en) 1990-07-10 1990-08-29 Brien Caroline J O Binding substance
US5789650A (en) 1990-08-29 1998-08-04 Genpharm International, Inc. Transgenic non-human animals for producing heterologous antibodies
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
US5770429A (en) 1990-08-29 1998-06-23 Genpharm International, Inc. Transgenic non-human animals capable of producing heterologous antibodies
US5874299A (en) 1990-08-29 1999-02-23 Genpharm International, Inc. Transgenic non-human animals capable of producing heterologous antibodies
US5625126A (en) 1990-08-29 1997-04-29 Genpharm International, Inc. Transgenic non-human animals for producing heterologous antibodies
KR100272077B1 (ko) 1990-08-29 2000-11-15 젠팜인터내셔날,인코포레이티드 이종 항체를 생산할 수 있는 전이유전자를 가진 인간이외의 동물
US6300129B1 (en) 1990-08-29 2001-10-09 Genpharm International Transgenic 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
US5661016A (en) 1990-08-29 1997-08-26 Genpharm International Inc. Transgenic non-human animals capable of producing heterologous antibodies of various isotypes
US5633425A (en) 1990-08-29 1997-05-27 Genpharm International, Inc. Transgenic non-human animals capable of producing heterologous antibodies
US5814318A (en) 1990-08-29 1998-09-29 Genpharm International Inc. Transgenic non-human animals for producing heterologous antibodies
ATE408012T1 (de) 1991-12-02 2008-09-15 Medical Res Council Herstellung von autoantikörpern auf phagenoberflächen ausgehend von antikörpersegmentbibliotheken
CA2124967C (en) 1991-12-17 2008-04-08 Nils Lonberg Transgenic non-human animals capable of producing heterologous antibodies
ES2091684T3 (es) 1992-11-13 1996-11-01 Idec Pharma Corp Aplicacion terapeutica de anticuerpos quimericos y radiomarcados contra el antigeno de diferenciacion restringida de los linfocitos b humanos para el tratamiento del linfoma de las celulas b.
AU6819494A (en) 1993-04-26 1994-11-21 Genpharm International, Inc. Transgenic non-human animals capable of producing heterologous antibodies
US5534615A (en) 1994-04-25 1996-07-09 Genentech, Inc. Cardiac hypertrophy factor and uses therefor
ATE321066T1 (de) * 1998-05-06 2006-04-15 Genentech Inc Anti-her2 antikörperzusammensetzung
EP1212422B1 (en) 1999-08-24 2007-02-21 Medarex, Inc. Human ctla-4 antibodies and their uses
DK1354034T3 (da) 2000-11-30 2008-03-25 Medarex Inc Transgene transchromosomale gnavere til fremstilling af humane antistoffer
JP4460302B2 (ja) 2002-02-05 2010-05-12 ジェネンテック インコーポレイテッド タンパク質精製法
US7763706B1 (en) * 2003-07-17 2010-07-27 Campina B.V. Arginine/lysine-enriched peptides
AU2004286938B2 (en) * 2003-10-27 2011-06-30 Wyeth Removal of high molecular weight aggregates using hydroxyapatite chromatography
DK1874933T3 (en) * 2005-04-26 2015-03-02 Sandoz Ag Preparation of recombinant proteins by autoproteolytic cleavage of a fusion protein
US8263750B2 (en) * 2006-03-16 2012-09-11 Amgen Inc. Method for purifying a protein using protein-A affinity chromatography using an intermediate wash step
ES2755386T5 (es) * 2006-08-28 2023-04-05 Ares Trading Sa Proceso para la purificación de proteínas que contienen fragmentos Fc
CL2007002615A1 (es) 2006-09-08 2008-04-18 Wyeth Corp Metodos para aislar o purificar un producto que comprende poner el producto enlazado en contacto con al menos una solucion de lavado que comprende arginina y luego eluir el producto; y dicho producto.
KR20110091678A (ko) * 2008-10-20 2011-08-12 아보트 러보러터리즈 단백질 ａ 친화성 크로마토그래피를 이용한 항체의 분리 및 정제
JP5909450B2 (ja) 2009-12-18 2016-04-26 ノバルティス アーゲー 洗浄溶液及びアフィニティークロマトグラフィーの方法
JP2012001462A (ja) 2010-06-15 2012-01-05 Kaneka Corp 抗体精製用カラム
CA2834300C (en) 2011-06-01 2022-01-11 Novartis Ag Wash solution and method for affinity chromatography
AR096713A1 (es) * 2013-06-25 2016-01-27 Cadila Healthcare Ltd Proceso de purificación para anticuerpos monoclonales
CA3190793A1 (en) * 2013-12-26 2015-07-02 Mitsubishi Tanabe Pharma Corporation Human anti-il-33 neutralizing monoclonal antibody
WO2016031932A1 (ja) 2014-08-27 2016-03-03 田辺三菱製薬株式会社 アルカリ洗浄によるＦｃ領域を有するタンパク質の製造方法
KR102490956B1 (ko) 2015-03-13 2023-01-19 브리스톨-마이어스 스큅 컴퍼니 불순물을 제거하기 위한 크로마토그래피 동안의 알칼리성 세척의 용도

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0280578A2 (en) * 1987-02-26 1988-08-31 Dana-Farber Cancer Institute, Inc. Purification of LFA-3
US5190859A (en) * 1987-02-26 1993-03-02 Dana-Farber Cancer Institute, Inc. Purification of LFA-3
US6172197B1 (en) * 1991-07-10 2001-01-09 Medical Research Council Methods for producing members of specific binding pairs
WO2009058812A1 (en) * 2007-10-30 2009-05-07 Genentech, Inc. Antibody purification by cation exchange chromatography

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
SHUKLA, A. et al., 'Host cell protein clearance during protein a chromatography: Development of an improved column wash step', Biotechnology Progress, 2008, Vol. 24, Issue 5, pages 1115-1121 *

Also Published As

Publication number Publication date
US12157073B2 (en) 2024-12-03
MX2017011121A (es) 2017-11-28
JP6807859B2 (ja) 2021-01-06
EA201792012A1 (ru) 2018-01-31
KR102490956B1 (ko) 2023-01-19
AU2021221870A1 (en) 2021-09-23
EP4194071A1 (en) 2023-06-14
WO2016149088A1 (en) 2016-09-22
SG10201908027QA (en) 2019-10-30
CA2978095C (en) 2022-02-15
US20200282332A1 (en) 2020-09-10
SG11201707330RA (en) 2017-10-30
CN107636005A (zh) 2018-01-26
IL254372B (en) 2022-05-01
EA035635B1 (ru) 2020-07-17
US10695693B2 (en) 2020-06-30
BR112017018365A2 (pt) 2018-04-10
MX395730B (es) 2025-03-25
KR20170125948A (ko) 2017-11-15
IL254372A0 (en) 2017-11-30
EP3268100A1 (en) 2018-01-17
CN107636005B (zh) 2021-07-16
US20180078876A1 (en) 2018-03-22
JP2018510867A (ja) 2018-04-19
AU2016233557A1 (en) 2017-11-02
CA2978095A1 (en) 2016-09-22

Similar Documents

Publication Publication Date Title
US12157073B2 (en) Use of alkaline washes during chromatography to remove impurities
US12157757B2 (en) Cation exchange chromatography methods
US20210009632A1 (en) Methods of purifying monomeric monoclonal antibodies
US8063189B2 (en) Protein purification by citrate precipitation
US20120101262A1 (en) Protein purification by caprylic acid (octanoic acid) precipitation
US20210054024A1 (en) Use of caprylic acid precipitation for protein purification
US20180105554A1 (en) Use of dextran sulfate to enhance protein a affinity chromatography
US20220162260A1 (en) Use of low ph and dextran sulfate during harvest treatment for protein purification

Legal Events

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