BR112022015920A2 - Método para determinar a razão de partículas de aav e uso do tempo de relaxação - Google Patents

Método para determinar a razão de partículas de aav e uso do tempo de relaxação

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Publication number
BR112022015920A2
BR112022015920A2 BR112022015920A BR112022015920A BR112022015920A2 BR 112022015920 A2 BR112022015920 A2 BR 112022015920A2 BR 112022015920 A BR112022015920 A BR 112022015920A BR 112022015920 A BR112022015920 A BR 112022015920A BR 112022015920 A2 BR112022015920 A2 BR 112022015920A2
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BR
Brazil
Prior art keywords
viral particles
ratio
empty
relaxation time
charged
Prior art date
Application number
BR112022015920A
Other languages
English (en)
Inventor
Funke Dinah
Hartl Maximilian
Original Assignee
Hoffmann La Roche
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.)
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Publication date
Application filed by Hoffmann La Roche filed Critical Hoffmann La Roche
Publication of BR112022015920A2 publication Critical patent/BR112022015920A2/pt

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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N24/00Investigating or analyzing materials by the use of nuclear magnetic resonance, electron paramagnetic resonance or other spin effects
    • G01N24/08Investigating or analyzing materials by the use of nuclear magnetic resonance, electron paramagnetic resonance or other spin effects by using nuclear magnetic resonance
    • G01N24/087Structure determination of a chemical compound, e.g. of a biomolecule such as a protein
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N30/62Detectors specially adapted therefor
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N24/00Investigating or analyzing materials by the use of nuclear magnetic resonance, electron paramagnetic resonance or other spin effects
    • G01N24/08Investigating or analyzing materials by the use of nuclear magnetic resonance, electron paramagnetic resonance or other spin effects by using nuclear magnetic resonance
    • G01N24/085Analysis of materials for the purpose of controlling industrial production systems
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • C07K1/18Ion-exchange chromatography
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N7/00Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N30/04Preparation or injection of sample to be analysed
    • G01N30/06Preparation
    • G01N30/14Preparation by elimination of some components
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N30/88Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01RMEASURING ELECTRIC VARIABLES; MEASURING MAGNETIC VARIABLES
    • G01R33/00Arrangements or instruments for measuring magnetic variables
    • G01R33/20Arrangements or instruments for measuring magnetic variables involving magnetic resonance
    • G01R33/44Arrangements or instruments for measuring magnetic variables involving magnetic resonance using nuclear magnetic resonance [NMR]
    • G01R33/448Relaxometry, i.e. quantification of relaxation times or spin density
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01RMEASURING ELECTRIC VARIABLES; MEASURING MAGNETIC VARIABLES
    • G01R33/00Arrangements or instruments for measuring magnetic variables
    • G01R33/20Arrangements or instruments for measuring magnetic variables involving magnetic resonance
    • G01R33/44Arrangements or instruments for measuring magnetic variables involving magnetic resonance using nuclear magnetic resonance [NMR]
    • G01R33/46NMR spectroscopy
    • G01R33/465NMR spectroscopy applied to biological material, e.g. in vitro testing
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2750/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssDNA viruses
    • C12N2750/00011Details
    • C12N2750/14011Parvoviridae
    • C12N2750/14111Dependovirus, e.g. adenoassociated viruses
    • C12N2750/14151Methods of production or purification of viral material
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N2030/022Column chromatography characterised by the kind of separation mechanism
    • G01N2030/027Liquid chromatography
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N30/88Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
    • G01N2030/8809Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample
    • G01N2030/8813Integrated 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
    • G01N2030/8831Integrated 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 involving peptides or proteins

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  • Physics & Mathematics (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • High Energy & Nuclear Physics (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Biochemistry (AREA)
  • Analytical Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Condensed Matter Physics & Semiconductors (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • Virology (AREA)
  • General Engineering & Computer Science (AREA)
  • Crystallography & Structural Chemistry (AREA)
  • Microbiology (AREA)
  • Peptides Or Proteins (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Magnetic Resonance Imaging Apparatus (AREA)
  • Investigating Or Analyzing Materials By The Use Of Magnetic Means (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Compounds Of Iron (AREA)
  • Investigating Or Analysing Materials By Optical Means (AREA)
  • Investigating, Analyzing Materials By Fluorescence Or Luminescence (AREA)

Abstract

MÉTODO PARA DETERMINAR A RAZÃO DE PARTÍCULAS DE AAV E USO DO TEMPO DE RELAXAÇÃO. A presente invenção baseia-se, pelo menos em parte, na descoberta de que o tempo de relaxação de rotação magnética nuclear transversal T2 e a taxa de relaxação de rotação magnética nuclear transversal R2, respectivamente, de prótons de moléculas de água em uma solução aquosa compreendendo partículas virais dependem do estado de carregamento (cheio versus vazio) da partícula viral. Assim, um aspecto da presente invenção é um método para determinar a razão de partículas virais carregadas para partículas virais vazias em uma amostra, compreendendo as etapas de determinar um parâmetro de ressonância magnética nuclear (RMN) relacionado aos prótons das moléculas de água presentes em uma solução aquosa compreendendo uma mistura de partículas virais carregadas e vazias aplicando uma medição de RMN à solução, e determinar a razão de partículas virais carregadas para partículas virais vazias com o parâmetro de RMN determinado na etapa anterior com base em uma função de calibração.
BR112022015920A 2020-02-13 2021-02-12 Método para determinar a razão de partículas de aav e uso do tempo de relaxação BR112022015920A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP20157222 2020-02-13
PCT/EP2021/053451 WO2021160799A1 (en) 2020-02-13 2021-02-12 Method for determining the loading state of an aav particle by nuclear magnetic resonance relaxometry

Publications (1)

Publication Number Publication Date
BR112022015920A2 true BR112022015920A2 (pt) 2022-10-04

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BR112022015920A BR112022015920A2 (pt) 2020-02-13 2021-02-12 Método para determinar a razão de partículas de aav e uso do tempo de relaxação

Country Status (11)

Country Link
US (2) US20230047531A1 (pt)
EP (2) EP4103937A1 (pt)
JP (2) JP2023513347A (pt)
KR (1) KR20220137672A (pt)
CN (2) CN115087861A (pt)
AU (1) AU2021219957A1 (pt)
BR (1) BR112022015920A2 (pt)
CA (1) CA3168607A1 (pt)
IL (1) IL295143A (pt)
MX (1) MX2022009642A (pt)
WO (2) WO2021160787A1 (pt)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117179737B (zh) * 2023-11-06 2024-02-20 哈尔滨医科大学 多核素同步一体化磁共振成像核素定量系统及其使用方法

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP6061853B2 (ja) 2010-07-30 2017-01-18 メディミューン,エルエルシー 活性ポリペプチドまたは免疫複合体の精製方法
US10267754B2 (en) 2013-04-12 2019-04-23 University Of Maryland, Baltimore Assessing biopharmaceutical aggregation using magnetic resonance relaxometry
PT3102595T (pt) 2014-02-06 2019-01-11 Hoffmann La Roche Proteínas de fusão de interleucina-2 e suas utilizações
US11346908B2 (en) 2016-12-02 2022-05-31 University Of Maryland, Baltimore Solvent nuclear magnetic resonance for noninvasive inspection of particle-containing products
BR112019017329A2 (pt) 2017-04-03 2020-04-14 Hoffmann La Roche imunoconjugados, um ou mais polinucleotídeos e vetores, métodos para a produção de um imunoconjugado, tratamento de uma doença e para a estimulação do sistema imunológico, composição, uso do imunoconjugado, invenção e usos da composição
GB201711481D0 (en) 2017-07-17 2017-08-30 Ucb Biopharma Sprl Protein purification

Also Published As

Publication number Publication date
WO2021160799A1 (en) 2021-08-19
AU2021219957A1 (en) 2022-08-04
EP4103937A1 (en) 2022-12-21
IL295143A (en) 2022-09-01
JP2023513347A (ja) 2023-03-30
CA3168607A1 (en) 2021-08-19
WO2021160787A1 (en) 2021-08-19
CN115135999A (zh) 2022-09-30
US20230047531A1 (en) 2023-02-16
US20220381750A1 (en) 2022-12-01
CN115087861A (zh) 2022-09-20
KR20220137672A (ko) 2022-10-12
MX2022009642A (es) 2022-09-07
JP2023513903A (ja) 2023-04-04
EP4103938A1 (en) 2022-12-21

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