BR112022005392A2 - Caracterização de partículas virais de terapia genética que usa cromatografia por exclusão de tamanho e tecnologias de dispersão de luz multiangular - Google Patents
Caracterização de partículas virais de terapia genética que usa cromatografia por exclusão de tamanho e tecnologias de dispersão de luz multiangularInfo
- Publication number
- BR112022005392A2 BR112022005392A2 BR112022005392A BR112022005392A BR112022005392A2 BR 112022005392 A2 BR112022005392 A2 BR 112022005392A2 BR 112022005392 A BR112022005392 A BR 112022005392A BR 112022005392 A BR112022005392 A BR 112022005392A BR 112022005392 A2 BR112022005392 A2 BR 112022005392A2
- Authority
- BR
- Brazil
- Prior art keywords
- viral particles
- size exclusion
- exclusion chromatography
- light scattering
- characterization
- Prior art date
Links
- 239000002245 particle Substances 0.000 title abstract 7
- 230000003612 virological effect Effects 0.000 title abstract 6
- 238000001542 size-exclusion chromatography Methods 0.000 title abstract 4
- 238000005516 engineering process Methods 0.000 title abstract 3
- 238000012512 characterization method Methods 0.000 title abstract 2
- 238000001415 gene therapy Methods 0.000 title abstract 2
- 238000000149 argon plasma sintering Methods 0.000 title 1
- 238000000569 multi-angle light scattering Methods 0.000 abstract 2
- 241000702421 Dependoparvovirus Species 0.000 abstract 1
- 241000713666 Lentivirus Species 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
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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
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- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/70—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving virus or bacteriophage
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- 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
- B01D15/34—Size selective separation, e.g. size exclusion chromatography, gel filtration, permeation
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- C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume, or surface-area of porous materials
- G01N15/02—Investigating particle size or size distribution
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume, or surface-area of porous materials
- G01N15/02—Investigating particle size or size distribution
- G01N15/0205—Investigating particle size or size distribution by optical means, e.g. by light scattering, diffraction, holography or imaging
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume, or surface-area of porous materials
- G01N15/06—Investigating concentration of particle suspensions
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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- C12N2740/00—Reverse transcribing RNA viruses
- C12N2740/00011—Details
- C12N2740/10011—Retroviridae
- C12N2740/15011—Lentivirus, not HIV, e.g. FIV, SIV
- C12N2740/15022—New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
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- C—CHEMISTRY; METALLURGY
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- C12N2740/00—Reverse transcribing RNA viruses
- C12N2740/00011—Details
- C12N2740/10011—Retroviridae
- C12N2740/15011—Lentivirus, not HIV, e.g. FIV, SIV
- C12N2740/15023—Virus like particles [VLP]
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- C12N2740/00—Reverse transcribing RNA viruses
- C12N2740/00011—Details
- C12N2740/10011—Retroviridae
- C12N2740/15011—Lentivirus, not HIV, e.g. FIV, SIV
- C12N2740/15051—Methods of production or purification of viral material
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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- 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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- C—CHEMISTRY; METALLURGY
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- C12N2750/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssDNA viruses
- C12N2750/00011—Details
- C12N2750/14011—Parvoviridae
- C12N2750/14111—Dependovirus, e.g. adenoassociated viruses
- C12N2750/14122—New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
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- C—CHEMISTRY; METALLURGY
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- C12N2750/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssDNA viruses
- C12N2750/00011—Details
- C12N2750/14011—Parvoviridae
- C12N2750/14111—Dependovirus, e.g. adenoassociated viruses
- C12N2750/14123—Virus like particles [VLP]
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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- C12N2750/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssDNA viruses
- C12N2750/00011—Details
- C12N2750/14011—Parvoviridae
- C12N2750/14111—Dependovirus, e.g. adenoassociated viruses
- C12N2750/14151—Methods of production or purification of viral material
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- G01N15/075—
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume, or surface-area of porous materials
- G01N2015/0038—Investigating nanoparticles
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- 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
- G01N2030/022—Column chromatography characterised by the kind of separation mechanism
- G01N2030/027—Liquid chromatography
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- 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
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- 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
- G01N30/62—Detectors specially adapted therefor
- G01N30/74—Optical detectors
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- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Genetics & Genomics (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Wood Science & Technology (AREA)
- Zoology (AREA)
- General Health & Medical Sciences (AREA)
- Biochemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Physics & Mathematics (AREA)
- Immunology (AREA)
- General Engineering & Computer Science (AREA)
- Biotechnology (AREA)
- Biomedical Technology (AREA)
- Analytical Chemistry (AREA)
- Microbiology (AREA)
- Virology (AREA)
- General Physics & Mathematics (AREA)
- Pathology (AREA)
- Medicinal Chemistry (AREA)
- Dispersion Chemistry (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Spectroscopy & Molecular Physics (AREA)
- Plant Pathology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
CARACTERIZAÇÃO DE PARTÍCULAS VIRAIS DE TERAPIA GENÉTICA QUE USA CROMATOGRAFIA POR EXCLUSÃO DE TAMANHO E TECNOLOGIAS DE DISPERSÃO DE LUZ MULTIANGULA. Esta divulgação refere-se ao uso de cromatografia por exclusão de tamanho e/ou cromatografia por exclusão de tamanho com tecnologia de dispersão de luz multiangular para caracterizar partículas virais, tais como vírus adenoassociado e partículas de lentivírus. Os métodos divulgados também são úteis para estimar o título de partículas virais, determinar a integridade das partículas virais e estimar a quantidade de DNA encapsulado na partícula viral.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201962907509P | 2019-09-27 | 2019-09-27 | |
US202063043571P | 2020-06-24 | 2020-06-24 | |
PCT/US2020/052738 WO2021062164A1 (en) | 2019-09-27 | 2020-09-25 | Characterization of gene therapy viral particles using size exclusion chromatography and multi-angle light scattering technologies |
Publications (1)
Publication Number | Publication Date |
---|---|
BR112022005392A2 true BR112022005392A2 (pt) | 2022-09-06 |
Family
ID=72964779
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
BR112022005392A BR112022005392A2 (pt) | 2019-09-27 | 2020-09-25 | Caracterização de partículas virais de terapia genética que usa cromatografia por exclusão de tamanho e tecnologias de dispersão de luz multiangular |
Country Status (11)
Country | Link |
---|---|
US (1) | US20220308022A1 (pt) |
EP (1) | EP4034642A1 (pt) |
JP (1) | JP2022549679A (pt) |
KR (1) | KR20220066164A (pt) |
CN (1) | CN114729333A (pt) |
AU (1) | AU2020354669A1 (pt) |
BR (1) | BR112022005392A2 (pt) |
CA (1) | CA3153782A1 (pt) |
IL (1) | IL291101A (pt) |
MX (1) | MX2022003681A (pt) |
WO (1) | WO2021062164A1 (pt) |
Families Citing this family (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2021236908A2 (en) | 2020-05-20 | 2021-11-25 | Biomarin Pharmaceutical Inc. | Use of regulatory proteins for the production of adeno-associated virus |
US20210396642A1 (en) * | 2020-06-18 | 2021-12-23 | Wyatt Technology Corporation | Calculating molar mass values of components of and molar mass concentration values of conjugate molecules/particles |
AU2021372262A1 (en) | 2020-11-02 | 2023-06-01 | Biomarin Pharmaceutical Inc. | Process for enriching adeno-associated virus |
WO2023034994A1 (en) | 2021-09-03 | 2023-03-09 | Biomarin Pharmaceutical Inc. | Aav capsid compositions and methods for delivery |
WO2023034990A1 (en) | 2021-09-03 | 2023-03-09 | Biomarin Pharmaceutical Inc. | Aav capsid compositions and methods for delivery |
WO2023034980A1 (en) | 2021-09-03 | 2023-03-09 | Bomarin Pharmaceutical Inc. | Aav capsid compositions and methods for delivery |
WO2023034997A1 (en) | 2021-09-03 | 2023-03-09 | Biomarin Pharmaceutical Inc. | Aav capsid compositions and methods for delivery |
WO2023034996A1 (en) | 2021-09-03 | 2023-03-09 | Biomarin Pharmaceutical Inc. | Aav capsid compositions and methods for delivery |
WO2023034989A1 (en) | 2021-09-03 | 2023-03-09 | Biomarin Pharmaceutical Inc. | Aav capsid compositions and methods for delivery |
WO2023056436A2 (en) | 2021-10-01 | 2023-04-06 | Biomarin Pharmaceutical Inc. | Treatment of hereditary angioedema with aav gene therapy vectors and therapeutic formulations |
WO2024054313A1 (en) * | 2022-09-07 | 2024-03-14 | Wyatt Technology, Llc | Measuring quality attributes of a virus sample |
Family Cites Families (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4745051A (en) | 1983-05-27 | 1988-05-17 | The Texas A&M University System | Method for producing a recombinant baculovirus expression vector |
EP0127839B1 (en) | 1983-05-27 | 1992-07-15 | THE TEXAS A&M UNIVERSITY SYSTEM | Method for producing a recombinant baculovirus expression vector |
ZA848495B (en) | 1984-01-31 | 1985-09-25 | Idaho Res Found | Production of polypeptides in insect cells |
US6204059B1 (en) | 1994-06-30 | 2001-03-20 | University Of Pittsburgh | AAV capsid vehicles for molecular transfer |
WO1998010088A1 (en) | 1996-09-06 | 1998-03-12 | Trustees Of The University Of Pennsylvania | An inducible method for production of recombinant adeno-associated viruses utilizing t7 polymerase |
US6723551B2 (en) | 2001-11-09 | 2004-04-20 | The United States Of America As Represented By The Department Of Health And Human Services | Production of adeno-associated virus in insect cells |
AU2003212708A1 (en) | 2002-03-05 | 2003-09-16 | Stichting Voor De Technische Wetenschappen | Baculovirus expression system |
US7943379B2 (en) | 2008-04-30 | 2011-05-17 | Nationwide Children's Hospital, Inc. | Production of rAAV in vero cells using particular adenovirus helpers |
EP3992283A1 (en) * | 2015-12-11 | 2022-05-04 | The Trustees Of The University Of Pennsylvania | Scalable purification method for aavrh10 |
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2020
- 2020-09-25 JP JP2022519130A patent/JP2022549679A/ja active Pending
- 2020-09-25 CN CN202080070612.1A patent/CN114729333A/zh active Pending
- 2020-09-25 AU AU2020354669A patent/AU2020354669A1/en active Pending
- 2020-09-25 US US17/635,488 patent/US20220308022A1/en active Pending
- 2020-09-25 MX MX2022003681A patent/MX2022003681A/es unknown
- 2020-09-25 WO PCT/US2020/052738 patent/WO2021062164A1/en active Application Filing
- 2020-09-25 CA CA3153782A patent/CA3153782A1/en active Pending
- 2020-09-25 KR KR1020227013806A patent/KR20220066164A/ko not_active Application Discontinuation
- 2020-09-25 BR BR112022005392A patent/BR112022005392A2/pt unknown
- 2020-09-25 EP EP20793841.6A patent/EP4034642A1/en active Pending
-
2022
- 2022-03-03 IL IL291101A patent/IL291101A/en unknown
Also Published As
Publication number | Publication date |
---|---|
US20220308022A1 (en) | 2022-09-29 |
MX2022003681A (es) | 2022-05-10 |
WO2021062164A1 (en) | 2021-04-01 |
CA3153782A1 (en) | 2022-03-08 |
EP4034642A1 (en) | 2022-08-03 |
CN114729333A (zh) | 2022-07-08 |
JP2022549679A (ja) | 2022-11-28 |
WO2021062164A9 (en) | 2021-05-14 |
AU2020354669A1 (en) | 2022-04-07 |
KR20220066164A (ko) | 2022-05-23 |
IL291101A (en) | 2022-05-01 |
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