BR112017008252A2 - isolamento contínuo integrado de correntes de fluido de recipientes de processo estéril - Google Patents

isolamento contínuo integrado de correntes de fluido de recipientes de processo estéril

Info

Publication number
BR112017008252A2
BR112017008252A2 BR112017008252A BR112017008252A BR112017008252A2 BR 112017008252 A2 BR112017008252 A2 BR 112017008252A2 BR 112017008252 A BR112017008252 A BR 112017008252A BR 112017008252 A BR112017008252 A BR 112017008252A BR 112017008252 A2 BR112017008252 A2 BR 112017008252A2
Authority
BR
Brazil
Prior art keywords
sterile
fluid streams
process vessel
sterile process
integrated continuous
Prior art date
Application number
BR112017008252A
Other languages
English (en)
Other versions
BR112017008252B1 (pt
Inventor
Snow Robert
Original Assignee
Genzyme Corp
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 Genzyme Corp filed Critical Genzyme Corp
Publication of BR112017008252A2 publication Critical patent/BR112017008252A2/pt
Publication of BR112017008252B1 publication Critical patent/BR112017008252B1/pt

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Classifications

    • 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
    • C12M1/00—Apparatus for enzymology or microbiology
    • 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
    • C12M1/00—Apparatus for enzymology or microbiology
    • C12M1/12—Apparatus for enzymology or microbiology with sterilisation, filtration or dialysis means
    • 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
    • C12M1/00—Apparatus for enzymology or microbiology
    • C12M1/26—Inoculator or sampler
    • 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
    • C12M23/00—Constructional details, e.g. recesses, hinges
    • C12M23/58—Reaction vessels connected in series or in parallel
    • 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
    • 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
    • C12M29/00—Means for introduction, extraction or recirculation of materials, e.g. pumps
    • C12M29/26—Conditioning fluids entering or exiting the reaction vessel
    • 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
    • C12M33/04—Means for introduction, transport, positioning, extraction, harvesting, peeling or sampling of biological material in or from the apparatus by injection or suction, e.g. using pipettes, syringes, needles
    • 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
    • C12M37/02—Filters
    • 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
    • C12M37/06—Means for testing the completeness of the sterilization
    • 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

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (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)
  • Molecular Biology (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Analytical Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Clinical Laboratory Science (AREA)
  • Medicinal Chemistry (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

a presente invenção refere-se a i processos de isolamento e hardware associado para permitir que as correntes de fluido sejam isoladas de um sistema esterilizado (por exemplo, um recipiente de processo estéril) que contém um processo estéril. os processos de isolamento aqui descritos permitem a remoção contínua de correntes de fluido (por exemplo, correntes de resíduos, líquido contendo proteína terapêutica recombinante) de um sistema esterilizado (por exemplo, um sistema de fabricação de produto biológico), que fornece menos manipulação manual do sistema esterilizado e um risco reduzido de contaminação do sistema esterilizado.
BR112017008252-7A 2014-10-24 2015-10-20 Método de inibir a contaminação de um sistema esterelizado BR112017008252B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201462068181P 2014-10-24 2014-10-24
US62/068,181 2014-10-24
PCT/US2015/056422 WO2016064846A1 (en) 2014-10-24 2015-10-20 Integrated continuous isolation of fluid streams from sterile process vessels

Publications (2)

Publication Number Publication Date
BR112017008252A2 true BR112017008252A2 (pt) 2017-12-26
BR112017008252B1 BR112017008252B1 (pt) 2022-03-03

Family

ID=54478962

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112017008252-7A BR112017008252B1 (pt) 2014-10-24 2015-10-20 Método de inibir a contaminação de um sistema esterelizado

Country Status (17)

Country Link
US (3) US20160115438A1 (pt)
EP (1) EP3209765B1 (pt)
JP (2) JP6672287B2 (pt)
KR (1) KR102465762B1 (pt)
CN (2) CN107109322B (pt)
AU (1) AU2015336130B2 (pt)
BR (1) BR112017008252B1 (pt)
CA (1) CA2965478C (pt)
DK (1) DK3209765T3 (pt)
ES (1) ES2931455T3 (pt)
HU (1) HUE060385T2 (pt)
IL (1) IL251819B (pt)
MX (1) MX2017005348A (pt)
RU (1) RU2713126C2 (pt)
SG (2) SG10201801943SA (pt)
TW (2) TWI691342B (pt)
WO (1) WO2016064846A1 (pt)

Families Citing this family (6)

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CN107109322B (zh) * 2014-10-24 2021-04-06 建新公司 从消毒处理容器一体化连续分离流体流
WO2019086324A1 (en) 2017-10-31 2019-05-09 Ge Healthcare Bio-Sciences Corp. A flexible bag
TWI747743B (zh) * 2021-02-22 2021-11-21 全淨然興業股份有限公司 胺基酸酵素自動生成活化設備
CN114947113A (zh) * 2021-02-24 2022-08-30 游家源 植物性胺基酸酵素制造方法及其设备
EP4339274A1 (en) * 2022-09-13 2024-03-20 Sartorius Stedim Biotech GmbH Method for operating a bioprocess installation for production of a bioproduct
JP7422925B1 (ja) 2023-07-19 2024-01-26 佐竹マルチミクス株式会社 バイオリアクター培養方法、及び、バイオリアクターの滅菌装置

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Also Published As

Publication number Publication date
AU2015336130A1 (en) 2017-06-08
CA2965478A1 (en) 2016-04-28
SG10201801943SA (en) 2018-05-30
EP3209765B1 (en) 2022-09-07
TW201625318A (zh) 2016-07-16
JP2017531444A (ja) 2017-10-26
RU2020102925A3 (pt) 2022-02-16
CA2965478C (en) 2023-03-14
JP6994526B2 (ja) 2022-02-21
RU2017115655A (ru) 2018-11-26
BR112017008252B1 (pt) 2022-03-03
DK3209765T3 (da) 2022-11-28
CN113105992B (zh) 2024-05-14
RU2020102925A (ru) 2021-07-26
US20160115438A1 (en) 2016-04-28
KR20170072932A (ko) 2017-06-27
HUE060385T2 (hu) 2023-02-28
WO2016064846A1 (en) 2016-04-28
ES2931455T3 (es) 2022-12-29
TWI740417B (zh) 2021-09-21
IL251819B (en) 2020-11-30
IL251819A0 (en) 2017-06-29
US11920120B2 (en) 2024-03-05
MX2017005348A (es) 2017-07-28
CN107109322B (zh) 2021-04-06
JP2020103307A (ja) 2020-07-09
RU2017115655A3 (pt) 2019-08-07
SG11201703265XA (en) 2017-05-30
CN113105992A (zh) 2021-07-13
US20210002601A1 (en) 2021-01-07
KR102465762B1 (ko) 2022-11-09
AU2015336130B2 (en) 2020-07-09
EP3209765A1 (en) 2017-08-30
TWI691342B (zh) 2020-04-21
TW202026016A (zh) 2020-07-16
US20220081669A1 (en) 2022-03-17
JP6672287B2 (ja) 2020-03-25
CN107109322A (zh) 2017-08-29
RU2713126C2 (ru) 2020-02-03

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B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B09W Correction of the decision to grant [chapter 9.1.4 patent gazette]

Free format text: RETIFICA-SE O DEFERIMENTO DA RPI 2659 DE 21/12/2021 POR TER SIDO EFETUADO COM INCORRECAO.

B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 20/10/2015, OBSERVADAS AS CONDICOES LEGAIS.