Improved multidetector asymmetrical-flow field-flow fractionation method for particle sizing and concentration measurements of lipid-based nanocarriers for RNA delivery

Mildner, Robert; Hak, Sjoerd; Parot, Jérémie; Hyldbakk, Astrid; Borgos, Sven Even F.; Some, D.; Johann, Christoph; Caputo, Fanny

doi:10.1016/j.ejpb.2021.03.004

Cited by 41 publications

(25 citation statements)

References 39 publications

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“…The developed method adhered to the standards a validated method must satisfy according to the harmonized guideline ICHQ2R1 and ISO/TS 21362 [ 40 , 41 ] and was, therefore, considered a standardized method and used to characterize all samples.…”

Section: Resultsmentioning

confidence: 99%

Application of Af4-Multidetection to Liraglutide in Its Formulation: Preserving and Representing Native Aggregation

Marassi

Macis²,

Giordani³

et al. 2022

Molecules

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Aggregation is among the most critical parameters affecting the pharmacological and safety profile of peptide Active Pharmaceutical Ingredients (APIs). For this reason, it is of utmost importance to define the exact aggregation state of peptide drugs, particularly when the API is marketed as a ready-to-use solution. Consequently, appropriate non-destructive techniques able to replicate the peptide environment must be employed. In our work, we exploited Asymmetrical Flow Field-Flow Fractionation (AF4), connected to UV, dRI, fluorescence, and MALS detectors, to fully characterize the aggregation state of Liraglutide, a peptide API used for the treatment of diabetes type 2 and chronic obesity. In previous studies, Liraglutide was hypothesized to assemble into hexa-octamers in phosphate buffer, but no information on its behavior in the formulation medium was provided up to now. The method used allowed researchers to work using formulation as the mobile phase with excellent recoveries and LoQ/LoD, discerning between stable and degraded samples, and detecting, when present, aggregates up to 108 Da. The native state of Liraglutide was assessed and found to be an association into pentamers, with a non-spherical conformation. Combined to benchmark analyses, the sameness study was complete and descriptive, also giving insight on the aggregation process and covalent/non-covalent aggregate types.

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Section: Resultsmentioning

confidence: 99%

Application of Af4-Multidetection to Liraglutide in Its Formulation: Preserving and Representing Native Aggregation

Marassi

Macis²,

Giordani³

et al. 2022

Molecules

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show abstract

“…These networks importantly contributed to the harmonization with issued guidance documents to translate more efficiently nanodrugs towards commercialisation. Related publications also showed the importance using several techniques to analyse more finally the nanoparticle shape and size distribution [ 235 ], highlighting also separation techniques which should be implemented prior to measuring the size distribution [ 236 ]. Industrial production of nanoparticles has also hampered their commercialisation.…”

Section: Discussionmentioning

confidence: 99%

Contribution of Nanotechnologies to Vaccine Development and Drug Delivery against Respiratory Viruses

et al. 2021

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According to the Center for Disease Control and Prevention (CDC), the coronavirus disease 2019, a respiratory viral illness linked to significant morbidity, mortality, production loss, and severe economic depression, was the third-largest cause of death in 2020. Respiratory viruses such as influenza, respiratory syncytial virus, SARS-CoV-2, and adenovirus, are among the most common causes of respiratory illness in humans, spreading as pandemics or epidemics throughout all continents. Nanotechnologies are particles in the nanometer range made from various compositions. They can be lipid-based, polymer-based, protein-based, or inorganic in nature, but they are all bioinspired and virus-like. In this review, we aimed to present a short review of the different nanoparticles currently studied, in particular those which led to publications in the field of respiratory viruses. We evaluated those which could be beneficial for respiratory disease-based viruses; those which already have contributed, such as lipid nanoparticles in the context of COVID-19; and those which will contribute in the future either as vaccines or antiviral drug delivery systems. We present a short assessment based on a critical selection of evidence indicating nanotechnology’s promise in the prevention and treatment of respiratory infections.

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“…A combination of multiangle light scattering, UV and refractive index detectors, coupled with size exclusion chromatography, is able to measure sizedependent RNA content in less than 1 h [91]. Alternatively, an asymmetric flow field-flow fraction method has recently been adapted to LNP-RNA inherent instability and is another robust and versatile approach for deeper LNP physical characterization [92,93]. More detailed information on LNP structure can be provided by other techniques (Table I).…”

Section: Trends In Biotechnologymentioning

confidence: 99%

Quality by Design for enabling RNA platform production processes

Daniel¹,

Kis²,

Kontoravdi³

et al. 2022

Trends in Biotechnology

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Improved multidetector asymmetrical-flow field-flow fractionation method for particle sizing and concentration measurements of lipid-based nanocarriers for RNA delivery

Cited by 41 publications

References 39 publications

Application of Af4-Multidetection to Liraglutide in Its Formulation: Preserving and Representing Native Aggregation

Application of Af4-Multidetection to Liraglutide in Its Formulation: Preserving and Representing Native Aggregation

Contribution of Nanotechnologies to Vaccine Development and Drug Delivery against Respiratory Viruses

Quality by Design for enabling RNA platform production processes

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