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US 2026/0086085 A1Published application
Methods of analyzing lipid nanoparticles in physiological fluids
AssigneeAgilent Technologies, Inc.
InventorsBrian Liau, Ravindra Gudihal
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Abstract
Methods and systems for analyzing lipid nanoparticles using size exclusion chromatograph coupled with multi angle light scattering are disclosed.
Claims20
A method of determining the stability of a lipid nanoparticle (LNP) in a subject, comprising:
- acquiring a first sample comprising the LNP from the subject;
- subjecting the first sample to a size-exclusion chromatography (SEC);
- acquiring a multi angle light scattering (MALS) signal from the first sample;
- acquiring a second sample comprising the LNP from the subject;
- subjecting the second sample to the SEC;
- acquiring a second MALS signal from the second sample;
- and
- comparing the first MALS signal and the second MALS signal,
- wherein the first and second samples comprise a physiological fluid, and wherein the comparison between the first MALS signal and the second MALS signal is indicative of the stability of the LNP in the subject,
- thereby determining the stability of the LNP in the subject.
7 more elements
A method of determining the purity of a lipid nanoparticle (LNP) in a sample, comprising:
- acquiring a first aliquot of the sample;
- subjecting the first aliquot to a size-exclusion chromatography (SEC);
- acquiring a multi angle light scattering (MALS) signal from the first aliquot;
- acquiring a second aliquot of the sample;
- subjecting the second aliquot to the SEC;
- acquiring a second MALS signal from the second aliquot;
- and
- comparing the first MALS signal and the second MALS signal to determine the stability of the LNP in the sample, which is indicative of the purity of the LNP in the sample,
- wherein the sample comprises a physiological fluid,
- thereby determining the purity of the LNP in the sample.
7 more elements
A method of monitoring a process of manufacturing a lipid nanoparticle (LNP), comprising:
- acquiring a first sample comprising an LNP from the process of manufacturing the LNP;
- subjecting the first sample to a size-exclusion chromatography (SEC);
- and
- acquiring a multi angle light scattering (MALS) signal from the first sample,
- acquiring a second sample comprising the LNP from the process of manufacturing the LNP;
- subjecting the second sample to the SEC;
- and
- acquiring a second MALS signal from the second sample,
- wherein the first and second samples comprise a physiological fluid,
- thereby monitoring the process of manufacturing the LNP.
7 more elements
Dependencies are inferred from the claim text.