CA2978095C - Use of alkaline washes during chromatography to remove impurities - Google Patents

Use of alkaline washes during chromatography to remove impurities Download PDF

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Publication number
CA2978095C
CA2978095C CA2978095A CA2978095A CA2978095C CA 2978095 C CA2978095 C CA 2978095C CA 2978095 A CA2978095 A CA 2978095A CA 2978095 A CA2978095 A CA 2978095A CA 2978095 C CA2978095 C CA 2978095C
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Prior art keywords
chromatography
protein
mab
cell culture
interest
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Active
Application number
CA2978095A
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English (en)
French (fr)
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CA2978095A1 (en
Inventor
Jue Wang
Neil E. JAFFE
Krina PATEL
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Bristol Myers Squibb Co
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Bristol Myers Squibb Co
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Publication of CA2978095A1 publication Critical patent/CA2978095A1/en
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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 [IG], e.g. monoclonal or polyclonal antibodies
    • 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
    • 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)
CA2978095A 2015-03-13 2016-03-11 Use of alkaline washes during chromatography to remove impurities Active CA2978095C (en)

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

Publications (2)

Publication Number Publication Date
CA2978095A1 CA2978095A1 (en) 2016-09-22
CA2978095C true CA2978095C (en) 2022-02-15

Family

ID=55699796

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2978095A Active CA2978095C (en) 2015-03-13 2016-03-11 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)

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WO2019246153A1 (en) * 2018-06-19 2019-12-26 Bristol-Myers Squibb Company Methods of purifying proteins using chromatography
SG11202101369XA (en) * 2018-08-17 2021-03-30 Regeneron Pharma Method and chromatography system for determining amount and purity of a multimeric protein
KR102270048B1 (ko) * 2020-07-10 2021-06-28 주식회사 녹십자 바리셀라 조스터 바이러스 표면 단백질 항원의 생산 방법
CA3116717A1 (en) * 2018-10-31 2020-05-07 Regeneron Pharmaceuticals, Inc. Method and system of identifying and quantifying a protein
US20210380638A1 (en) * 2018-12-21 2021-12-09 WuXi Biologics Ireland Limited A method for improving aggregate removal by Protein A chromatography
SG11202106370WA (en) 2019-01-16 2021-07-29 Regeneron Pharma Method and system of identifying and quantifying antibody fragmentation
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
KR20260058863A (ko) * 2019-09-24 2026-04-29 리제너론 파아마슈티컬스, 인크. 크로마토그래피의 사용 및 재생을 위한 시스템 및 방법
CN114599971A (zh) * 2019-10-14 2022-06-07 皮尔斯生物科技有限公司 肽纯化配制物和方法
JP7817945B2 (ja) * 2020-03-27 2026-02-19 ハエマロジックス・リミテッド 組成物および方法
PE20231507A1 (es) * 2020-10-02 2023-09-26 Lilly Co Eli Metodos para reducir el contenido de proteinas de la celula huesped en procesos de purificacion de anticuerpos y composiciones de anticuerpos que tienen un contenido reducido de proteinas de la celula huesped
TW202600582A (zh) * 2024-02-20 2026-01-01 美商艾克塞里克斯公司 用於蛋白質純化之方法

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Also Published As

Publication number Publication date
IL254372A0 (en) 2017-11-30
CN107636005A (zh) 2018-01-26
MX2017011121A (es) 2017-11-28
KR102490956B1 (ko) 2023-01-19
MX395730B (es) 2025-03-25
CN107636005B (zh) 2021-07-16
SG11201707330RA (en) 2017-10-30
US12157073B2 (en) 2024-12-03
US10695693B2 (en) 2020-06-30
KR20170125948A (ko) 2017-11-15
IL254372B (en) 2022-05-01
AU2016233557B2 (en) 2021-06-24
SG10201908027QA (en) 2019-10-30
EP4194071A1 (en) 2023-06-14
EA201792012A1 (ru) 2018-01-31
EP3268100A1 (en) 2018-01-17
BR112017018365A2 (pt) 2018-04-10
AU2016233557A1 (en) 2017-11-02
US20200282332A1 (en) 2020-09-10
JP2018510867A (ja) 2018-04-19
WO2016149088A1 (en) 2016-09-22
AU2021221870A1 (en) 2021-09-23
US20180078876A1 (en) 2018-03-22
JP6807859B2 (ja) 2021-01-06
CA2978095A1 (en) 2016-09-22
EA035635B1 (ru) 2020-07-17

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