WO2024054313A1 - Mesure d'attributs de qualité d'un échantillon de virus - Google Patents
Mesure d'attributs de qualité d'un échantillon de virus Download PDFInfo
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- WO2024054313A1 WO2024054313A1 PCT/US2023/028754 US2023028754W WO2024054313A1 WO 2024054313 A1 WO2024054313 A1 WO 2024054313A1 US 2023028754 W US2023028754 W US 2023028754W WO 2024054313 A1 WO2024054313 A1 WO 2024054313A1
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Classifications
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
- G01N21/41—Refractivity; Phase-affecting properties, e.g. optical path length
- G01N21/4133—Refractometers, e.g. differential
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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
- G01N15/0211—Investigating a scatter or diffraction pattern
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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
- G01N15/10—Investigating individual particles
- G01N15/14—Electro-optical investigation, e.g. flow cytometers
- G01N15/1434—Electro-optical investigation, e.g. flow cytometers using an analyser being characterised by its optical arrangement
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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
- G01N15/10—Investigating individual particles
- G01N15/14—Electro-optical investigation, e.g. flow cytometers
- G01N15/1456—Electro-optical investigation, e.g. flow cytometers without spatial resolution of the texture or inner structure of the particle, e.g. processing of pulse signals
- G01N15/1459—Electro-optical investigation, e.g. flow cytometers without spatial resolution of the texture or inner structure of the particle, e.g. processing of pulse signals the analysis being performed on a sample stream
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
- G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
- G01N21/31—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
- G01N21/33—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using ultraviolet light
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
- G01N21/47—Scattering, i.e. diffuse reflection
- G01N21/49—Scattering, i.e. diffuse reflection within a body or fluid
- G01N21/51—Scattering, i.e. diffuse reflection within a body or fluid inside a container, e.g. in an ampoule
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- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
- G01N33/6803—General methods of protein analysis not limited to specific proteins or families of proteins
- G01N33/6827—Total protein determination, e.g. albumin in urine
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- G—PHYSICS
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- 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
- G01N15/0211—Investigating a scatter or diffraction pattern
- G01N2015/0222—Investigating a scatter or diffraction pattern from dynamic light scattering, e.g. photon correlation spectroscopy
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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
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
- G01N21/41—Refractivity; Phase-affecting properties, e.g. optical path length
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- G01N2021/4146—Differential cell arrangements
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- G—PHYSICS
- G01—MEASURING; TESTING
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- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
- G01N21/47—Scattering, i.e. diffuse reflection
- G01N2021/4704—Angular selective
- G01N2021/4711—Multiangle measurement
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
- G01N21/47—Scattering, i.e. diffuse reflection
- G01N2021/4792—Polarisation of scatter light
Abstract
La présente divulgation concerne un procédé mis en œuvre par ordinateur, un système et un produit-programme informatique de mesure d'attributs de qualité d'un échantillon de virus. Selon un mode de réalisation, le procédé, le système et le produit de programme informatique comprennent (1) la réception de données de diffusion de lumière (LS) provenant d'un détecteur de diffusion de lumière analysant des séparations d'un échantillon de virus, de données dRI et de données UV, (2) la réception d'un poids moléculaire d'un composant de protéine de l'échantillon, Mprotéine (attendue), d'un incrément d'indice de réfraction du composant de protéine, (dn/dc)protéine, d'un incrément d'indice de réfraction d'un composant d'ADN de l'échantillon, (dn/dc)ADN, et d'un coefficient d'extinction du composant de protéine, εprotéine, (3), le calcul d'une fraction de protéine de l'échantillon, xprotéine, par rapport aux données LS, aux données dRI, au Mprotéine M (attendue), au (dn/dc)protéine , au (dn/dc)ADN, et une constante optique, K, (4) le calcul d'un coefficient d'extinction d'ADN de l'échantillon, εADN, et (5) le calcul des valeurs d'attribut de qualité de l'échantillon.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US17/939,950 US20230112910A1 (en) | 2021-09-07 | 2022-09-07 | Measuring quality attributes of a virus sample |
| US17/939,950 | 2022-09-07 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2024054313A1 true WO2024054313A1 (fr) | 2024-03-14 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US2023/028754 WO2024054313A1 (fr) | 2022-09-07 | 2023-07-27 | Mesure d'attributs de qualité d'un échantillon de virus |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2024054313A1 (fr) |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2021062164A1 (fr) * | 2019-09-27 | 2021-04-01 | Biomarin Pharmaceutical Inc. | Caractérisation de particules virales de thérapie génique à l'aide de technologies de chromatographie d'exclusion stérique et de diffusion de lumière multi-angle |
| US20210231560A1 (en) * | 2018-04-29 | 2021-07-29 | Regenxbio Inc. | Systems and methods of spectrophotometry for the determination of genome content, capsid content and full/empty ratios of adeno-associated virus particles |
-
2023
- 2023-07-27 WO PCT/US2023/028754 patent/WO2024054313A1/fr unknown
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20210231560A1 (en) * | 2018-04-29 | 2021-07-29 | Regenxbio Inc. | Systems and methods of spectrophotometry for the determination of genome content, capsid content and full/empty ratios of adeno-associated virus particles |
| WO2021062164A1 (fr) * | 2019-09-27 | 2021-04-01 | Biomarin Pharmaceutical Inc. | Caractérisation de particules virales de thérapie génique à l'aide de technologies de chromatographie d'exclusion stérique et de diffusion de lumière multi-angle |
Non-Patent Citations (6)
| Title |
|---|
| COLL DE PEÑA ADRIANA ET AL: "Electrophoresis-Mediated Characterization of Full and Empty Adeno-Associated Virus Capsids", ACS OMEGA, vol. 7, no. 27, 29 June 2022 (2022-06-29) - 29 June 2022 (2022-06-29), US, pages 23457 - 23466, XP093081510, ISSN: 2470-1343, Retrieved from the Internet <URL:https://pubs.acs.org/doi/pdf/10.1021/acsomega.2c01813> [retrieved on 20231024], DOI: 10.1021/acsomega.2c01813 * |
| ENGLANDER S W ET AL: "Optical methods for measuring nucleoprotein and nucleic acid concentrations", ARCHIVES OF BIOCHEMISTRY AND BIOPHYSICS, ACADEMIC PRESS, US, vol. 68, no. 1, 1 May 1957 (1957-05-01), pages 144 - 149, XP024808071, ISSN: 0003-9861, [retrieved on 19570501], DOI: 10.1016/0003-9861(57)90334-X * |
| PELJHAN SEBASTIJAN ET AL: "Multiple-parameter profiling of density gradient ultracentrifugation for characterization of empty and full capsid distribution in AAV preparations", CELL AND GENE THERAPY INSIGHTS, vol. 7, no. 2, 16 March 2021 (2021-03-16), pages 161 - 169, XP055888694, ISSN: 2059-7800, DOI: 10.18609/cgti.2021.039 * |
| PORTERFIELD J Z ET AL: "A simple and general method for determining the protein and nucleic acid content of viruses by UV absorbance", VIROLOGY, ELSEVIER, AMSTERDAM, NL, vol. 407, no. 2, 25 November 2010 (2010-11-25), pages 281 - 288, XP027402374, ISSN: 0042-6822, [retrieved on 20101007] * |
| SOMMER J M ET AL: "Quantification of adeno-associated virus particles and empty capsids by optical density measurement", MOLECULAR THERAPY, ELSEVIER INC, US, vol. 7, no. 1, 1 January 2003 (2003-01-01), pages 122 - 128, XP002965707, ISSN: 1525-0016, DOI: 10.1016/S1525-0016(02)00019-9 * |
| YAMAZAKI H ET AL: "Isolation and characterization of a protein subunit of broad bean mottle virus", JOURNAL OF MOLECULAR BIOLOGY, ACADEMIC PRESS, UNITED KINGDOM, vol. 6, no. 6, 1 June 1963 (1963-06-01), pages 465 - 473, XP026092950, ISSN: 0022-2836, [retrieved on 19630601], DOI: 10.1016/S0022-2836(63)80058-3 * |
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