CO2024000891A2 - Ensayo de cromatografía líquida para determinar la relación de la cápside de aav - Google Patents

Ensayo de cromatografía líquida para determinar la relación de la cápside de aav

Info

Publication number
CO2024000891A2
CO2024000891A2 CONC2024/0000891A CO2024000891A CO2024000891A2 CO 2024000891 A2 CO2024000891 A2 CO 2024000891A2 CO 2024000891 A CO2024000891 A CO 2024000891A CO 2024000891 A2 CO2024000891 A2 CO 2024000891A2
Authority
CO
Colombia
Prior art keywords
liquid chromatography
aav capsid
chromatography assay
ratio
determine aav
Prior art date
Application number
CONC2024/0000891A
Other languages
English (en)
Inventor
Dingjiang Liu
Jonathan Wert
Li Zhi
Original Assignee
Regeneron Pharma
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 Regeneron Pharma filed Critical Regeneron Pharma
Publication of CO2024000891A2 publication Critical patent/CO2024000891A2/es

Links

Classifications

    • 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
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • 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
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/569—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
    • G01N33/56983—Viruses
    • 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
    • B01D15/10—Selective adsorption, e.g. chromatography characterised by constructional or operational features
    • B01D15/18—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to flow patterns
    • B01D15/1864—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to flow patterns using two or more columns
    • B01D15/1871—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to flow patterns using two or more columns placed in series
    • B01D15/1878—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to flow patterns using two or more columns placed in series for multi-dimensional chromatography
    • 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
    • B01D15/30—Partition chromatography
    • B01D15/305—Hydrophilic interaction chromatography [HILIC]
    • 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
    • B01D15/32—Bonded phase chromatography
    • B01D15/325—Reversed phase
    • 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
    • B01D15/36—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction
    • B01D15/361—Ion-exchange
    • B01D15/363—Anion-exchange
    • 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
    • G01N30/72—Mass spectrometers
    • G01N30/7233—Mass spectrometers interfaced to liquid or supercritical fluid chromatograph
    • 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
    • G01N30/72—Mass spectrometers
    • G01N30/7233—Mass spectrometers interfaced to liquid or supercritical fluid chromatograph
    • G01N30/724—Nebulising, aerosol formation or ionisation
    • G01N30/7266—Nebulising, aerosol formation or ionisation by electric field, e.g. electrospray
    • 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
    • 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
    • G01N30/86—Signal analysis
    • G01N30/8675—Evaluation, i.e. decoding of the signal into analytical information
    • G01N30/8679—Target compound analysis, i.e. whereby a limited number of peaks is analysed
    • 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
    • G01N30/96—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 using ion-exchange
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • 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
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/5308—Immunoassay; Biospecific binding assay; Materials therefor for analytes not provided for elsewhere, e.g. nucleic acids, uric acid, worms, mites
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • 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
    • G01N33/6848—Methods of protein analysis involving mass spectrometry
    • 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
    • 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
    • G01N2030/8831—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 involving peptides or proteins
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/005—Assays involving biological materials from specific organisms or of a specific nature from viruses
    • G01N2333/01—DNA viruses
    • G01N2333/015—Parvoviridae, e.g. feline panleukopenia virus, human Parvovirus
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2440/00—Post-translational modifications [PTMs] in chemical analysis of biological material
    • G01N2440/10—Post-translational modifications [PTMs] in chemical analysis of biological material acylation, e.g. acetylation, formylation, lipoylation, myristoylation, palmitoylation
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2440/00—Post-translational modifications [PTMs] in chemical analysis of biological material
    • G01N2440/14—Post-translational modifications [PTMs] in chemical analysis of biological material phosphorylation
    • 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
    • G01N30/26—Conditioning of the fluid carrier; Flow patterns
    • G01N30/28—Control of physical parameters of the fluid carrier
    • G01N30/34—Control of physical parameters of the fluid carrier of fluid composition, e.g. gradient

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Urology & Nephrology (AREA)
  • Food Science & Technology (AREA)
  • Biotechnology (AREA)
  • Cell Biology (AREA)
  • Microbiology (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Virology (AREA)
  • Bioinformatics & Computational Biology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dispersion Chemistry (AREA)
  • Library & Information Science (AREA)
  • Other Investigation Or Analysis Of Materials By Electrical Means (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)

Abstract

Se describen métodos para determinar la abundancia relativa de los componentes de la cápside de virus adenoasociado (AAV) intacta en una muestra de partículas de AAV recombinante. En las modalidades, los métodos incluyen un proceso de regeneración del sistema que minimiza o elimina la presencia de picos fantasma para maximizar la exactitud analítica y garantizar la calidad y consistencia del producto.
CONC2024/0000891A 2021-07-12 2024-01-30 Ensayo de cromatografía líquida para determinar la relación de la cápside de aav CO2024000891A2 (es)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US202163220651P 2021-07-12 2021-07-12
US202163275138P 2021-11-03 2021-11-03
US202263359554P 2022-07-08 2022-07-08
US202263359557P 2022-07-08 2022-07-08
PCT/US2022/036728 WO2023287725A1 (en) 2021-07-12 2022-07-11 Liquid chromatography assay for determining aav capsid ratio

Publications (1)

Publication Number Publication Date
CO2024000891A2 true CO2024000891A2 (es) 2024-02-05

Family

ID=82748615

Family Applications (2)

Application Number Title Priority Date Filing Date
CONC2024/0000891A CO2024000891A2 (es) 2021-07-12 2024-01-30 Ensayo de cromatografía líquida para determinar la relación de la cápside de aav
CONC2024/0000911A CO2024000911A2 (es) 2021-07-12 2024-01-30 Métodos para la caracterización de partículas víricas mediante cromatografía de líquidos bidimensional-espectrometría de masas

Family Applications After (1)

Application Number Title Priority Date Filing Date
CONC2024/0000911A CO2024000911A2 (es) 2021-07-12 2024-01-30 Métodos para la caracterización de partículas víricas mediante cromatografía de líquidos bidimensional-espectrometría de masas

Country Status (9)

Country Link
US (2) US20230016717A1 (es)
EP (2) EP4370715A1 (es)
KR (2) KR20240032973A (es)
AU (2) AU2022309726A1 (es)
CA (2) CA3225338A1 (es)
CO (2) CO2024000891A2 (es)
IL (2) IL309733A (es)
TW (2) TW202319394A (es)
WO (2) WO2023287723A1 (es)

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TN2019000047A1 (en) * 2016-08-15 2020-07-15 Genzyme Corp Methods for detecting aav
JP2022540478A (ja) * 2019-07-12 2022-09-15 サンガモ セラピューティクス， インコーポレイテッド 空のおよび完全なウイルスキャプシド粒子の分離および定量化
MX2022008003A (es) * 2020-01-03 2022-10-07 Sarepta Therapeutics Inc Métodos para analizar proteínas de la cápside de aav.

Also Published As

Publication number Publication date
CO2024000911A2 (es) 2024-02-05
EP4370914A1 (en) 2024-05-22
CA3225332A1 (en) 2023-01-19
AU2022309726A1 (en) 2024-01-25
CA3225338A1 (en) 2023-01-19
TW202321692A (zh) 2023-06-01
AU2022309725A1 (en) 2024-01-25
US20230020428A1 (en) 2023-01-19
IL309733A (en) 2024-02-01
IL309763A (en) 2024-02-01
KR20240032973A (ko) 2024-03-12
WO2023287723A1 (en) 2023-01-19
EP4370715A1 (en) 2024-05-22
KR20240031375A (ko) 2024-03-07
TW202319394A (zh) 2023-05-16
US20230016717A1 (en) 2023-01-19
WO2023287725A1 (en) 2023-01-19

Similar Documents

Publication Publication Date Title
Macías et al. Comparison of six commercial serum exosome isolation methods suitable for clinical laboratories. Effect in cytokine analysis
Benedikter et al. Ultrafiltration combined with size exclusion chromatography efficiently isolates extracellular vesicles from cell culture media for compositional and functional studies
Boğdaycioğlu et al. Comparison of iSED and Ves‐Matic Cube 200 erythrocyte sedimentation rate measurements with Westergren method
CN106546671A (zh) 基于三柱二维液质联用法测定肉制品中残留磺胺类药物的方法
Schroder et al. Methylmalonic acid quantified in dried blood spots provides a precise, valid, and stable measure of functional vitamin B-12 status in healthy women
BRPI0513526A (pt) componentes de aparelho e métodos de utilizar componentes de aparelho para detectar a presença de um analisado
Jackson et al. Rapid isolation of extracellular vesicles from diverse biofluid matrices via capillary-channeled polymer fiber solid-phase extraction micropipette tips
Liénard et al. Modular instrumentation for capillary electrophoresis with laser induced fluorescence detection using plug-and-play microfluidic, electrophoretic and optic modules
CO2024000891A2 (es) Ensayo de cromatografía líquida para determinar la relación de la cápside de aav
Kogawa et al. Eco-friendly pharmaceutical analysis of rifaximin in tablets by HPLC-MS and microbiological turbidimetry
Carolina Kogawa et al. Method indicative of stability for the determination of rifaximin and its degradation products by thin chromatographic
Fernández‐Rhodes et al. Defining the influence of size‐exclusion chromatography fraction window and ultrafiltration column choice on extracellular vesicle recovery in a skeletal muscle model
CN105136967B (zh) 用于鉴别贡菊和亳菊的反相薄层色谱方法
Ioannou et al. Stereoselective separation of psychoactive substances: Multivariate optimization and validation of a capillary electrophoresis method using carboxymethyl-β-CD/deep eutectic solvent dual system
Wu et al. Separation and characterization of biomacromolecules, bionanoparticles, and biomicroparticles using flow field-flow fractionation: Current applications and prospects
Delanghe et al. Quantification of carbamylated albumin in serum based on capillary electrophoresis
Jacob et al. Assessment of Chinese medicinal herb metabolite profiles by UPLC‐MS‐based methodology for the detection of aristolochic acids
Korman et al. High-throughput method for the quantification of lacosamide in serum using ultrafast SPE-MS/MS
CN104215718B (zh) Triton X-100含量的高效液相色谱检测方法
Essam et al. Stepwise optimization and sensitivity improvement of green micellar electrokinetic chromatography method to simultaneously determine some fluoroquinolones and glucocorticoids present in various binary ophthalmic formulations
Hussain et al. Ultra high performance liquid chromatography (UPLC): a new Trend in analysis
CN104458969B (zh) 重组酿酒酵母表达的HBsAg原液中Triton X-100残留量的测定方法
Zacharis et al. Automated sample preparation coupled to sequential injection chromatography: On-line filtration and dilution protocols prior to separation
Opitz et al. The removal of Triton X-100 by dialysis is feasible!
Barbatsi et al. A new flow-injection chromatography method exploiting linear-gradient elution for fast quantitative screening of parabens in cosmetics