CA3209216A1 - Methods for purification of recombinant proteins - Google Patents

Methods for purification of recombinant proteins Download PDF

Info

Publication number
CA3209216A1
CA3209216A1 CA3209216A CA3209216A CA3209216A1 CA 3209216 A1 CA3209216 A1 CA 3209216A1 CA 3209216 A CA3209216 A CA 3209216A CA 3209216 A CA3209216 A CA 3209216A CA 3209216 A1 CA3209216 A1 CA 3209216A1
Authority
CA
Canada
Prior art keywords
chromatography
column
pool
elution
protein
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.)
Pending
Application number
CA3209216A
Other languages
English (en)
French (fr)
Inventor
Neil Soice
Jeremy S. Conner
Glenn M. HUNTER
Kenneth Shoemaker
Bret WYLIE
John B. Flynn
Nakorn KAEONIL
Thuy N. Nguyen
Siddharth Singh
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 CA3209216A1 publication Critical patent/CA3209216A1/en
Pending legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • B01D15/1885—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to flow patterns using two or more columns placed in parallel
    • 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
    • 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
    • C07K1/36—Extraction; Separation; Purification by a combination of two or more processes of different types
    • 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
    • G01N30/60—Construction of the column
    • G01N30/6034—Construction of the column joining multiple columns
    • 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
    • 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)
  • Analytical Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
CA3209216A 2021-03-10 2022-03-10 Methods for purification of recombinant proteins Pending CA3209216A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202163159217P 2021-03-10 2021-03-10
US63/159,217 2021-03-10
PCT/US2022/019697 WO2022192504A1 (en) 2021-03-10 2022-03-10 Methods for purification of recombinant proteins

Publications (1)

Publication Number Publication Date
CA3209216A1 true CA3209216A1 (en) 2022-09-15

Family

ID=80952165

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3209216A Pending CA3209216A1 (en) 2021-03-10 2022-03-10 Methods for purification of recombinant proteins

Country Status (9)

Country Link
US (1) US20240051990A1 (https=)
EP (1) EP4305048A1 (https=)
JP (1) JP2024509877A (https=)
KR (1) KR20230154908A (https=)
CN (1) CN117043173A (https=)
AU (1) AU2022234768A1 (https=)
CA (1) CA3209216A1 (https=)
IL (1) IL304571A (https=)
WO (1) WO2022192504A1 (https=)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2024235093A1 (en) * 2023-03-14 2025-09-04 Amgen Inc. Anion exchange chromatography processes using a primary amine ligand
US20240426793A1 (en) * 2023-06-20 2024-12-26 Amgen Inc. Methods for chromatography and chromatography medium reuse
WO2025262319A1 (en) * 2024-06-21 2025-12-26 Boehringer Ingelheim International Gmbh Modifying blue color formation in bioprocesses

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CZ302070B6 (cs) 1998-04-21 2010-09-29 Micromet Ag Jednoretezcový multifunkcní polypeptid, polynukleotid, vektor obsahující tento polynukleotid, bunka transfekovaná tímto polynukleotidem, prostredek obsahující tento polypeptid, polynukleotid nebo vektor a jejich použití a zpusob identifikace aktiváto
DE602004030811D1 (de) 2003-10-16 2011-02-10 Micromet Ag Multispezifische deimmunisierte cd3-bindende moleküle
RS53008B2 (sr) 2007-04-03 2022-12-30 Amgen Res Munich Gmbh Interspecijski specifičan cd3-epsilon vezujući domen
EP2820047B1 (en) 2012-03-01 2018-04-25 Amgen Research (Munich) GmbH Long life polypeptide binding molecules
EP2656892A1 (en) * 2012-04-23 2013-10-30 Merck Patent GmbH Chromatography method
SG10201709131UA (en) * 2013-03-08 2017-12-28 Genzyme Corp Continuous purification of therapeutic proteins
US20140302037A1 (en) 2013-03-15 2014-10-09 Amgen Inc. BISPECIFIC-Fc MOLECULES
AU2014236769B2 (en) 2013-03-15 2018-09-27 Amgen Inc. Heterodimeric bispecific antibodies
US20140308285A1 (en) 2013-03-15 2014-10-16 Amgen Inc. Heterodimeric bispecific antibodies
WO2014140358A1 (en) 2013-03-15 2014-09-18 Amgen Research (Munich) Gmbh Single chain binding molecules comprising n-terminal abp
EP3733710A1 (en) 2013-09-25 2020-11-04 Amgen, Inc Hetrodimeric v-c-fc-v-c antibody
EA039859B1 (ru) 2015-07-31 2022-03-21 Эмджен Рисерч (Мюник) Гмбх Биспецифические конструкты антител, связывающие egfrviii и cd3

Also Published As

Publication number Publication date
US20240051990A1 (en) 2024-02-15
EP4305048A1 (en) 2024-01-17
AU2022234768A1 (en) 2023-07-27
JP2024509877A (ja) 2024-03-05
IL304571A (en) 2023-09-01
KR20230154908A (ko) 2023-11-09
WO2022192504A1 (en) 2022-09-15
CN117043173A (zh) 2023-11-10

Similar Documents

Publication Publication Date Title
AU2020216108B2 (en) A continuous manufacturing process for biologics manufacturing by integration of drug substance and drug product processes
US20240051990A1 (en) Methods for purification of recombinant proteins
US20240075406A1 (en) Parallel chromatography systems and methods
US20170058308A1 (en) Integrated continuous biomanufacturing process
US20230058276A1 (en) Methods for harvesting biomolecules
US20260070943A1 (en) A method for harvesting products from high cell density perfusion cell cultures
US20230416667A1 (en) In-process verification of calibration status of ph probes
US20250288957A1 (en) Intensified ultrafiltration/diafiltration processes
WO2025251034A1 (en) Purification method
EA047584B1 (ru) ПРОВЕРКА В ПРОЦЕССЕ СОСТОЯНИЯ КАЛИБРОВКИ pH-ЗОНДОВ
EA049616B1 (ru) Непрерывный способ изготовления биопрепаратов посредством интеграции процессов получения лекарственного вещества и лекарственного препарата

Legal Events

Date Code Title Description
MFA Maintenance fee for application paid

Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 3RD ANNIV.) - STANDARD

Year of fee payment: 3

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-1-1-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20250221

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-1-1-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20250912

MFA Maintenance fee for application paid

Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 4TH ANNIV.) - STANDARD

Year of fee payment: 4

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-1-1-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20260220

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-1-1-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20260220

D11 Substantive examination requested

Free format text: ST27 STATUS EVENT CODE: A-1-1-D10-D11-D117 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: REQUEST FOR EXAMINATION RECEIVED

Effective date: 20260306

P11 Amendment of application requested

Free format text: ST27 STATUS EVENT CODE: A-1-1-P10-P11-P101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: AMENDMENT RECEIVED - VOLUNTARY AMENDMENT

Effective date: 20260306

W00 Other event occurred

Free format text: ST27 STATUS EVENT CODE: A-1-1-W10-W00-W111 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: CORRESPONDENT DETERMINED COMPLIANT

Effective date: 20260306

D00 Search and/or examination requested or commenced

Free format text: ST27 STATUS EVENT CODE: A-1-1-D10-D00-D118 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: REQUEST FOR EXAMINATION REQUIREMENTS DETERMINED COMPLIANT

Effective date: 20260318

D11 Substantive examination requested

Free format text: ST27 STATUS EVENT CODE: A-1-2-D10-D11-D155 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: ALL REQUIREMENTS FOR EXAMINATION DETERMINED COMPLIANT

Effective date: 20260318

P11 Amendment of application requested

Free format text: ST27 STATUS EVENT CODE: A-1-1-P10-P11-P102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: AMENDMENT DETERMINED COMPLIANT

Effective date: 20260318

P13 Application amended

Free format text: ST27 STATUS EVENT CODE: A-1-1-P10-P13-X000 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: APPLICATION AMENDED

Effective date: 20260318

W00 Other event occurred

Free format text: ST27 STATUS EVENT CODE: A-1-1-W10-W00-W111 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: CORRESPONDENT DETERMINED COMPLIANT

Effective date: 20260318

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: 20260318