JP7252896B2 - 生物学的産物バリアントを産生する方法 - Google Patents

生物学的産物バリアントを産生する方法 Download PDF

Info

Publication number
JP7252896B2
JP7252896B2 JP2019544727A JP2019544727A JP7252896B2 JP 7252896 B2 JP7252896 B2 JP 7252896B2 JP 2019544727 A JP2019544727 A JP 2019544727A JP 2019544727 A JP2019544727 A JP 2019544727A JP 7252896 B2 JP7252896 B2 JP 7252896B2
Authority
JP
Japan
Prior art keywords
variant
product
cells
protein variant
bioreactor
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
JP2019544727A
Other languages
English (en)
Japanese (ja)
Other versions
JP2020507336A5 (enExample
JP2020507336A (ja
Inventor
ベリ、ラジェシ
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.)
Lonza AG
Original Assignee
Lonza AG
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 Lonza AG filed Critical Lonza AG
Publication of JP2020507336A publication Critical patent/JP2020507336A/ja
Publication of JP2020507336A5 publication Critical patent/JP2020507336A5/ja
Application granted granted Critical
Publication of JP7252896B2 publication Critical patent/JP7252896B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
    • C12N5/0018—Culture media for cell or tissue culture
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/02—Peptides of undefined number of amino acids; Derivatives thereof
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M29/00—Means for introduction, extraction or recirculation of materials, e.g. pumps
    • C12M29/10—Perfusion
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M47/00—Means for after-treatment of the produced biomass or of the fermentation or metabolic products, e.g. storage of biomass
    • C12M47/12—Purification
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2500/00—Specific components of cell culture medium
    • C12N2500/05—Inorganic components
    • C12N2500/10—Metals; Metal chelators
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2500/00—Specific components of cell culture medium
    • C12N2500/30—Organic components
    • C12N2500/32—Amino acids
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2500/00—Specific components of cell culture medium
    • C12N2500/30—Organic components
    • C12N2500/34—Sugars
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2501/00—Active agents used in cell culture processes, e.g. differentation
    • C12N2501/70—Enzymes
    • C12N2501/73—Hydrolases (EC 3.)
    • C12N2501/734—Proteases (EC 3.4.)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2510/00—Genetically modified cells
    • C12N2510/02—Cells for production

Landscapes

  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biotechnology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Organic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Genetics & Genomics (AREA)
  • General Health & Medical Sciences (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Sustainable Development (AREA)
  • Cell Biology (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Immunology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)
JP2019544727A 2017-02-17 2018-02-16 生物学的産物バリアントを産生する方法 Active JP7252896B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201762460387P 2017-02-17 2017-02-17
US62/460,387 2017-02-17
PCT/US2018/000030 WO2018151819A1 (en) 2017-02-17 2018-02-16 A method for producing biologic product variants

Publications (3)

Publication Number Publication Date
JP2020507336A JP2020507336A (ja) 2020-03-12
JP2020507336A5 JP2020507336A5 (enExample) 2021-03-25
JP7252896B2 true JP7252896B2 (ja) 2023-04-05

Family

ID=61691554

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2019544727A Active JP7252896B2 (ja) 2017-02-17 2018-02-16 生物学的産物バリアントを産生する方法

Country Status (7)

Country Link
US (2) US20190382718A1 (enExample)
EP (1) EP3571289A1 (enExample)
JP (1) JP7252896B2 (enExample)
KR (1) KR102701102B1 (enExample)
CN (1) CN110494554A (enExample)
IL (1) IL268602B2 (enExample)
WO (1) WO2018151819A1 (enExample)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008131374A1 (en) 2007-04-23 2008-10-30 Wyeth Use of low temperature and/or low ph in cell culture
WO2013158273A1 (en) 2012-04-20 2013-10-24 Abbvie Inc. Methods to modulate c-terminal lysine variant distribution
JP2017504344A (ja) 2014-01-29 2017-02-09 エルジー ライフ サイエンシーズ リミテッドＬｇ Ｌｉｆｅ Ｓｃｉｅｎｃｅｓ Ｌｔｄ． 培養培地の最適化により組換えタンパク質のガラクトシル化を調節する方法

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT1258959B (it) 1992-06-09 1996-03-11 Impianto a moduli mobili per lo sviluppo e la produzione di prodotti biotecnologici su scala pilota
US6090382A (en) * 1996-02-09 2000-07-18 Basf Aktiengesellschaft Human antibodies that bind human TNFα
MXPA06008724A (es) 2004-02-03 2007-02-16 Xcellerex Llc Sistema y metodo para elaboracion.
US7629167B2 (en) 2004-06-04 2009-12-08 Xcellerex, Inc. Disposable bioreactor systems and methods
EP2004798A4 (en) 2005-12-05 2010-11-24 Ernest G Hope PREVALIDED, MODULAR GOODS MANUFACTURING PRACTICE CORRESPONDING ESTABLISHMENT
PT2137655E (pt) 2007-04-16 2012-09-14 Momenta Pharmaceuticals Inc Produtos de glicoproteína definidos e métodos relacionados
WO2010138502A2 (en) * 2009-05-26 2010-12-02 Momenta Pharmaceuticals, Inc. Production of glycoproteins
WO2011139708A2 (en) 2010-04-26 2011-11-10 Toyota Motor Engineering & Manufacturing North America, Inc. Improved hydrogen release from complex metal hydrides by solvation in ionic liquids
US10371394B2 (en) 2010-09-20 2019-08-06 Biologics Modular Llc Mobile, modular cleanroom facility
US9388373B2 (en) 2011-03-08 2016-07-12 University Of Maryland Baltimore County Microscale bioprocessing system and method for protein manufacturing

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008131374A1 (en) 2007-04-23 2008-10-30 Wyeth Use of low temperature and/or low ph in cell culture
WO2013158273A1 (en) 2012-04-20 2013-10-24 Abbvie Inc. Methods to modulate c-terminal lysine variant distribution
JP2017504344A (ja) 2014-01-29 2017-02-09 エルジー ライフ サイエンシーズ リミテッドＬｇ Ｌｉｆｅ Ｓｃｉｅｎｃｅｓ Ｌｔｄ． 培養培地の最適化により組換えタンパク質のガラクトシル化を調節する方法

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
Biotechnol. Prog.，2016年，Vol.32, No.5，p.1123-1134
Biotechnology and Bioengineering，2011年，Vol.108, No.10，p.2348-2358

Also Published As

Publication number Publication date
US20240067923A1 (en) 2024-02-29
IL268602B1 (en) 2024-08-01
WO2018151819A1 (en) 2018-08-23
KR102701102B1 (ko) 2024-08-29
JP2020507336A (ja) 2020-03-12
IL268602B2 (en) 2024-12-01
CN110494554A (zh) 2019-11-22
KR20190117624A (ko) 2019-10-16
EP3571289A1 (en) 2019-11-27
IL268602A (en) 2019-09-26
US20190382718A1 (en) 2019-12-19

Similar Documents

Publication Publication Date Title
JP7584206B2 (ja) タンパク質の安定化方法
KR20180074775A (ko) 생물약제의 생산을 위한 제조 설비
JP7404453B2 (ja) 細胞選択方法及び細胞代謝改変方法
US12054733B2 (en) Universal self-regulating mammalian cell line platform for the production of biologics
JP7252896B2 (ja) 生物学的産物バリアントを産生する方法
US20210324390A1 (en) Methods for improving production of biological products by reducing the level of endogenous protein
EP3942014A1 (en) Continuous blade impeller
HK40017333A (en) A method for producing biologic product variants
HK40019706B (zh) 用於生产生物制品的通用自调节哺乳动物细胞系平台

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20210212

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20210212

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20211029

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20211203

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20220302

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20220622

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20220921

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20221122

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20230301

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20230324

R150 Certificate of patent or registration of utility model

Ref document number: 7252896

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150