EA202191826A1 - Автоматизированные комплексные непрерывные система и биопроцесс для продукции терапевтического белка - Google Patents

Автоматизированные комплексные непрерывные система и биопроцесс для продукции терапевтического белка

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Publication number
EA202191826A1
EA202191826A1 EA202191826A EA202191826A EA202191826A1 EA 202191826 A1 EA202191826 A1 EA 202191826A1 EA 202191826 A EA202191826 A EA 202191826A EA 202191826 A EA202191826 A EA 202191826A EA 202191826 A1 EA202191826 A1 EA 202191826A1
Authority
EA
Eurasian Patent Office
Prior art keywords
bioprocess
therapeutic protein
production
automated
continuous
Prior art date
Application number
EA202191826A
Other languages
English (en)
Inventor
Хришикеш Бартаке
Химаншу Гаджил
Абир БАНЕРДЖИ
Харшита Лондхе
Абиджар Бхори
Абхиджит Бутти
Самир Варма
Рохан Годсе
Вирендра Редди
Original Assignee
Энзен Биосайенсес Лимитед
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 Энзен Биосайенсес Лимитед filed Critical Энзен Биосайенсес Лимитед
Publication of EA202191826A1 publication Critical patent/EA202191826A1/ru

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    • 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
    • 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
    • C12M29/04—Filters; Permeable or porous membranes or plates, e.g. dialysis
    • 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
    • C12M33/00—Means for introduction, transport, positioning, extraction, harvesting, peeling or sampling of biological material in or from the apparatus
    • C12M33/14—Means for introduction, transport, positioning, extraction, harvesting, peeling or sampling of biological material in or from the apparatus with filters, sieves or membranes
    • 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
    • C12M37/00—Means for sterilizing, maintaining sterile conditions or avoiding chemical or biological contamination
    • 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
    • C12M41/00—Means for regulation, monitoring, measurement or control, e.g. flow regulation
    • C12M41/26—Means for regulation, monitoring, measurement or control, e.g. flow regulation of pH
    • 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
    • C12M41/00—Means for regulation, monitoring, measurement or control, e.g. flow regulation
    • C12M41/30—Means for regulation, monitoring, measurement or control, e.g. flow regulation of concentration
    • C12M41/32—Means for regulation, monitoring, measurement or control, e.g. flow regulation of concentration of substances in solution
    • 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
    • C12M41/00—Means for regulation, monitoring, measurement or control, e.g. flow regulation
    • C12M41/44—Means for regulation, monitoring, measurement or control, e.g. flow regulation of volume or liquid level
    • 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
    • C12M41/00—Means for regulation, monitoring, measurement or control, e.g. flow regulation
    • C12M41/48—Automatic or computerized control
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12P—FERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTURE
    • C12P21/00—Preparation of peptides or proteins

Landscapes

  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biotechnology (AREA)
  • Genetics & Genomics (AREA)
  • General Health & Medical Sciences (AREA)
  • Microbiology (AREA)
  • General Engineering & Computer Science (AREA)
  • Biochemistry (AREA)
  • Sustainable Development (AREA)
  • Biomedical Technology (AREA)
  • Analytical Chemistry (AREA)
  • Molecular Biology (AREA)
  • Computer Hardware Design (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)

Abstract

Настоящее изобретение относится к системе автоматизированного комплексного непрерывного биопроцесса и биопроцессу, которые позволяют непрерывно продуцировать терапевтический белок и масштабируются от лабораторного до промышленного масштаба. В настоящем изобретении предложена система автоматизированного комплексного непрерывного биопроцесса и биопроцесс для продукции терапевтического белка, причем указанные система и процесс управляются одной или более системой управления, выбранными из системы (110) внешнего управления и сбора данных, пропорционально-интегрально-дифференциального регулирования (PID), программируемой логической схемы (PLC), промышленного ПК (IPC), распределенной системы управления (DCS) и системы ретрансляции сообщений, а также автоматизированный пробоотбор при СЭЖХ/ВЭЖХ для анализа в ходе работы с целью запуска системы и процесса без перерывов и непрерывной продукции терапевтического белка.
EA202191826A 2019-01-25 2019-04-01 Автоматизированные комплексные непрерывные система и биопроцесс для продукции терапевтического белка EA202191826A1 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN201921003147 2019-01-25
PCT/IB2019/052654 WO2020152509A1 (en) 2019-01-25 2019-04-01 Automated integrated continuous system and bioprocess for producing therapeutic protein

Publications (1)

Publication Number Publication Date
EA202191826A1 true EA202191826A1 (ru) 2021-12-31

Family

ID=66397360

Family Applications (1)

Application Number Title Priority Date Filing Date
EA202191826A EA202191826A1 (ru) 2019-01-25 2019-04-01 Автоматизированные комплексные непрерывные система и биопроцесс для продукции терапевтического белка

Country Status (8)

Country Link
US (1) US20220090001A1 (ru)
EP (1) EP3914691A1 (ru)
JP (2) JP7365419B2 (ru)
KR (1) KR20210120015A (ru)
CN (1) CN113490738A (ru)
AU (1) AU2019423931A1 (ru)
EA (1) EA202191826A1 (ru)
WO (1) WO2020152509A1 (ru)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20220119759A1 (en) * 2020-10-19 2022-04-21 Emd Millipore Corporation Cascade Tangential Flow Filtration Systems for Perfusion of Cell Culture
US20220127558A1 (en) * 2020-10-23 2022-04-28 Applied Materials, Inc. Automated closed system for cell therapy manufacturing
KR20230107266A (ko) * 2020-11-09 2023-07-14 암젠 인크 pH 프로브의 교정 상태의 공정 중 검증
WO2022248623A1 (en) * 2021-05-26 2022-12-01 Simabs Nv Integrated continuous bioprocess production platform
CN113419576A (zh) * 2021-07-08 2021-09-21 安徽伊普诺康生物技术股份有限公司 一种蛋白分析仪温控系统
CN113999767A (zh) * 2021-11-02 2022-02-01 安及义实业（上海）有限公司 一种哺乳动物细胞培养的不锈钢生物反应器及其使用方法
WO2023188937A1 (ja) * 2022-03-30 2023-10-05 富士フイルム株式会社 バイオ医薬品の原薬の製造方法、バイオ医薬品の原薬の製造システム、およびバイオ医薬品の原薬
CN116200244B (zh) * 2023-05-04 2023-09-15 赛奥斯博生物科技(北京)有限公司 一种细胞培养病毒液分离纯化设备及纯化方法

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2662929C2 (ru) * 2013-03-08 2018-07-31 Джензим Корпорейшн Интегрированное непрерывное производство терапевтических белковых лекарственных веществ
TWI707949B (zh) * 2014-06-09 2020-10-21 美商健臻公司 種子罐培養法（ｓｅｅｄ ｔｒａｉｎ ｐｒｏｃｅｓｓｅｓ）及其用途

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US20220090001A1 (en) 2022-03-24
JP2022523682A (ja) 2022-04-26
JP7365419B2 (ja) 2023-10-19
AU2019423931A1 (en) 2021-08-19
EP3914691A1 (en) 2021-12-01
KR20210120015A (ko) 2021-10-06
JP2023126887A (ja) 2023-09-12
WO2020152509A1 (en) 2020-07-30
CN113490738A (zh) 2021-10-08

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