CN115698305A - 用于制造病毒载体的方法 - Google Patents

用于制造病毒载体的方法 Download PDF

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Publication number
CN115698305A
CN115698305A CN202180038239.6A CN202180038239A CN115698305A CN 115698305 A CN115698305 A CN 115698305A CN 202180038239 A CN202180038239 A CN 202180038239A CN 115698305 A CN115698305 A CN 115698305A
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sptff
viral vector
kda
filtration
filtration module
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CN202180038239.6A
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English (en)
Chinese (zh)
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布伦特·朱利安·科伊斯曼
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Regeneron Pharmaceuticals Inc
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2 Savinti Biology
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    • 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
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/63—Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C12N15/79—Vectors or expression systems specially adapted for eukaryotic hosts
    • C12N15/85—Vectors or expression systems specially adapted for eukaryotic hosts for animal cells
    • C12N15/86—Viral vectors
    • 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
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/63—Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C12N15/64—General methods for preparing the vector, for introducing it into the cell or for selecting the vector-containing host
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/14—Ultrafiltration; Microfiltration
    • B01D61/145—Ultrafiltration
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/02—Reverse osmosis; Hyperfiltration ; Nanofiltration
    • B01D61/027—Nanofiltration
    • B01D61/0271—Nanofiltration comprising multiple nanofiltration steps
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/02—Reverse osmosis; Hyperfiltration ; Nanofiltration
    • B01D61/029—Multistep processes comprising different kinds of membrane processes selected from reverse osmosis, hyperfiltration or nanofiltration
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/14—Ultrafiltration; Microfiltration
    • B01D61/147—Microfiltration
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/14—Ultrafiltration; Microfiltration
    • B01D61/147—Microfiltration
    • B01D61/1471—Microfiltration comprising multiple microfiltration steps
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/14—Ultrafiltration; Microfiltration
    • B01D61/149—Multistep processes comprising different kinds of membrane processes selected from ultrafiltration or microfiltration
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D63/00—Apparatus in general for separation processes using semi-permeable membranes
    • B01D63/02—Hollow fibre modules
    • B01D63/028—Microfluidic devices comprising semi-permeable hollow fibre membranes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D63/00—Apparatus in general for separation processes using semi-permeable membranes
    • B01D63/08—Flat membrane modules
    • 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
    • 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
    • C07K1/34—Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2311/00—Details relating to membrane separation process operations and control
    • B01D2311/04—Specific process operations in the feed stream; Feed pretreatment
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2311/00—Details relating to membrane separation process operations and control
    • B01D2311/26—Further operations combined with membrane separation processes
    • B01D2311/2623—Ion-Exchange
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2311/00—Details relating to membrane separation process operations and control
    • B01D2311/26—Further operations combined with membrane separation processes
    • B01D2311/2688—Biological processes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2311/00—Details relating to membrane separation process operations and control
    • B01D2311/26—Further operations combined with membrane separation processes
    • B01D2311/2697—Chromatography
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2315/00—Details relating to the membrane module operation
    • B01D2315/10—Cross-flow filtration
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2315/00—Details relating to the membrane module operation
    • B01D2315/16—Diafiltration
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2317/00—Membrane module arrangements within a plant or an apparatus
    • B01D2317/02—Elements in series
    • B01D2317/022—Reject series
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2317/00—Membrane module arrangements within a plant or an apparatus
    • B01D2317/02—Elements in series
    • B01D2317/027—Christmas tree arrangements
    • 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
    • C12N2740/00—Reverse transcribing RNA viruses
    • C12N2740/00011—Details
    • C12N2740/10011—Retroviridae
    • C12N2740/16011—Human Immunodeficiency Virus, HIV
    • C12N2740/16041—Use of virus, viral particle or viral elements as a vector
    • C12N2740/16043—Use of virus, viral particle or viral elements as a vector viral genome or elements thereof as genetic vector
    • 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
    • C12N2740/00—Reverse transcribing RNA viruses
    • C12N2740/00011—Details
    • C12N2740/10011—Retroviridae
    • C12N2740/16011—Human Immunodeficiency Virus, HIV
    • C12N2740/16051—Methods of production or purification of viral material

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  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Water Supply & Treatment (AREA)
  • Genetics & Genomics (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nanotechnology (AREA)
  • Wood Science & Technology (AREA)
  • Biomedical Technology (AREA)
  • Zoology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Engineering & Computer Science (AREA)
  • Biotechnology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Microbiology (AREA)
  • Plant Pathology (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicinal Chemistry (AREA)
  • Virology (AREA)
  • Dispersion Chemistry (AREA)
  • Cell Biology (AREA)
  • Separation Using Semi-Permeable Membranes (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
CN202180038239.6A 2020-06-11 2021-06-10 用于制造病毒载体的方法 Pending CN115698305A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202063037777P 2020-06-11 2020-06-11
US63/037,777 2020-06-11
PCT/US2021/036840 WO2021252782A1 (en) 2020-06-11 2021-06-10 Methods for manufacturing viral vectors

Publications (1)

Publication Number Publication Date
CN115698305A true CN115698305A (zh) 2023-02-03

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CN202180038239.6A Pending CN115698305A (zh) 2020-06-11 2021-06-10 用于制造病毒载体的方法

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US (1) US20230212591A1 (https=)
EP (1) EP4165197A4 (https=)
JP (1) JP2023528776A (https=)
KR (1) KR20230024891A (https=)
CN (1) CN115698305A (https=)
AU (1) AU2021286651A1 (https=)
CA (1) CA3194520A1 (https=)
WO (1) WO2021252782A1 (https=)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4252882A1 (en) * 2022-03-31 2023-10-04 Sartorius Stedim Biotech GmbH Separation system for separating and purifying a target component
EP4400583A1 (en) 2023-01-12 2024-07-17 Sartorius Stedim Biotech GmbH Method for generating and purifying viral vectors
EP4689044A1 (en) * 2023-04-03 2026-02-11 Genzyme Corporation Devices for cell lysis and methods of use thereof
WO2025087829A1 (en) * 2023-10-24 2025-05-01 Merck Patent Gmbh Continuous filtration by means of feed cycling

Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040167320A1 (en) * 2003-02-24 2004-08-26 Couto Daniel E. Methods of tangential flow filtration and an apparatus therefore
US20120219588A1 (en) * 2008-09-24 2012-08-30 Mark Thompson Methods for purification of viruses
CN104395341A (zh) * 2012-06-29 2015-03-04 Emd密理博公司 生物分子的纯化
US20150361129A1 (en) * 2014-06-16 2015-12-17 Emd Millipore Corporation Methods for increasing the capacity of flow-through processes
CN105378074A (zh) * 2013-03-15 2016-03-02 费城儿童医院 在无血清悬浮细胞培养系统中生产重组慢病毒载体的可扩大的制造方法
CN105745009A (zh) * 2014-08-29 2016-07-06 Emd 密理博公司 单程切向流过滤系统和具有渗余物的再循环的切向流过滤系统
CN105980571A (zh) * 2013-12-17 2016-09-28 吉尼松公司 用于纯化包膜病毒或病毒载体的方法
CN106457153A (zh) * 2014-03-07 2017-02-22 新加坡科技研究局 用于分级分离生物制品的装置和方法
WO2019199476A1 (en) * 2018-04-12 2019-10-17 Amgen Inc. Methods for making stable protein compositions
WO2019236811A1 (en) * 2018-06-08 2019-12-12 Bristol-Myers Squibb Company Single pass tangential flow filtration hybrid configurations for enhancing concentration of macromolecule solutions
WO2020037249A1 (en) * 2018-08-16 2020-02-20 Rocket Pharmaceuticals, Ltd. Production methods for viral vectors

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102575233B (zh) * 2009-10-15 2014-07-16 克鲁塞尔荷兰公司 从高细胞密度培养物纯化腺病毒的方法

Patent Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040167320A1 (en) * 2003-02-24 2004-08-26 Couto Daniel E. Methods of tangential flow filtration and an apparatus therefore
US20120219588A1 (en) * 2008-09-24 2012-08-30 Mark Thompson Methods for purification of viruses
CN104395341A (zh) * 2012-06-29 2015-03-04 Emd密理博公司 生物分子的纯化
CN105378074A (zh) * 2013-03-15 2016-03-02 费城儿童医院 在无血清悬浮细胞培养系统中生产重组慢病毒载体的可扩大的制造方法
CN105980571A (zh) * 2013-12-17 2016-09-28 吉尼松公司 用于纯化包膜病毒或病毒载体的方法
CN106457153A (zh) * 2014-03-07 2017-02-22 新加坡科技研究局 用于分级分离生物制品的装置和方法
US20150361129A1 (en) * 2014-06-16 2015-12-17 Emd Millipore Corporation Methods for increasing the capacity of flow-through processes
CN105745009A (zh) * 2014-08-29 2016-07-06 Emd 密理博公司 单程切向流过滤系统和具有渗余物的再循环的切向流过滤系统
WO2019199476A1 (en) * 2018-04-12 2019-10-17 Amgen Inc. Methods for making stable protein compositions
WO2019236811A1 (en) * 2018-06-08 2019-12-12 Bristol-Myers Squibb Company Single pass tangential flow filtration hybrid configurations for enhancing concentration of macromolecule solutions
WO2020037249A1 (en) * 2018-08-16 2020-02-20 Rocket Pharmaceuticals, Ltd. Production methods for viral vectors

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Publication number Publication date
AU2021286651A1 (en) 2023-01-19
EP4165197A1 (en) 2023-04-19
US20230212591A1 (en) 2023-07-06
KR20230024891A (ko) 2023-02-21
EP4165197A4 (en) 2024-07-03
CA3194520A1 (en) 2021-12-16
WO2021252782A1 (en) 2021-12-16
JP2023528776A (ja) 2023-07-06

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