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dc.contributor.authorMerlo-Mas, Josep
dc.contributor.authorTomsen-Melero, Judit
dc.contributor.authorCorchero, José-Luis
dc.contributor.authorGonzález-Mira, Elisabet
dc.contributor.authorFont, Albert
dc.contributor.authorPedersen, Jannik N.
dc.contributor.authorGarcía-Aranda, Natalia
dc.contributor.authorCristóbal-Lecina, Edgar
dc.contributor.authorAlcaina-Hernando, Marta
dc.contributor.authorMendoza, Rosa
dc.contributor.authorGarcia-Fruitós, Elena
dc.contributor.authorLizarraga, Teresa
dc.contributor.authorResch, Susanne
dc.contributor.authorSchimpel, Christa
dc.contributor.authorFalk, Andreas
dc.contributor.authorPulido, Daniel
dc.contributor.authorRoyo, Miriam
dc.contributor.authorSchwartz Jr., Simó
dc.contributor.authorAbasolo, Ibane
dc.contributor.authorPedersen, Jan Skov
dc.contributor.authorDanino, Dganit
dc.contributor.authorSoldevila, Andreu
dc.contributor.authorVeciana, Jaume
dc.contributor.authorSala, Santi
dc.contributor.authorVentosa, Nora
dc.contributor.authorCórdoba, Alba
dc.contributor.otherProducció Animalca
dc.date.accessioned2022-02-08T10:46:43Z
dc.date.available2022-02-08T10:46:43Z
dc.date.issued2021-02-19
dc.identifier.citationMerlo-Mas, Josep, Judit Tomsen-Melero, José-Luis Corchero, Elisabet González-Mira, Albert Font, Jannik N. Pedersen, and Natalia García-Aranda et al. 2021. "Application Of Quality By Design To The Robust Preparation Of A Liposomal GLA Formulation By DELOS-Susp Method". The Journal Of Supercritical Fluids 173: 105204. doi:10.1016/j.supflu.2021.105204.ca
dc.identifier.issn0896-8446ca
dc.identifier.urihttp://hdl.handle.net/20.500.12327/1599
dc.description.abstractFabry disease is a lysosomal storage disease arising from a deficiency of the enzyme α-galactosidase A (GLA). The enzyme deficiency results in an accumulation of glycolipids, which over time, leads to cardiovascular, cerebrovascular, and renal disease, ultimately leading to death in the fourth or fifth decade of life. Currently, lysosomal storage disorders are treated by enzyme replacement therapy (ERT) through the direct administration of the missing enzyme to the patients. In view of their advantages as drug delivery systems, liposomes are increasingly being researched and utilized in the pharmaceutical, food and cosmetic industries, but one of the main barriers to market is their scalability. Depressurization of an Expanded Liquid Organic Solution into aqueous solution (DELOS-susp) is a compressed fluid-based method that allows the reproducible and scalable production of nanovesicular systems with remarkable physicochemical characteristics, in terms of homogeneity, morphology, and particle size. The objective of this work was to optimize and reach a suitable formulation for in vivo preclinical studies by implementing a Quality by Design (QbD) approach, a methodology recommended by the FDA and the EMA to develop robust drug manufacturing and control methods, to the preparation of α-galactosidase-loaded nanoliposomes (nanoGLA) for the treatment of Fabry disease. Through a risk analysis and a Design of Experiments (DoE), we obtained the Design Space in which GLA concentration and lipid concentration were found as critical parameters for achieving a stable nanoformulation. This Design Space allowed the optimization of the process to produce a nanoformulation suitable for in vivo preclinical testing.ca
dc.format.extent15ca
dc.language.isoengca
dc.publisherElsevierca
dc.relation.ispartofJournal of Supercritical Fluidsca
dc.rightsAttribution 4.0 Internationalca
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/*
dc.titleApplication of Quality by Design to the robust preparation of a liposomal GLA formulation by DELOS-susp methodca
dc.typeinfo:eu-repo/semantics/articleca
dc.description.versioninfo:eu-repo/semantics/publishedVersionca
dc.rights.accessLevelinfo:eu-repo/semantics/openAccess
dc.embargo.termscapca
dc.relation.projectIDEC/H2020/720942/EU/Smart multifunctional GLA-nanoformulation for Fabry disease/Smart-4-Fabryca
dc.relation.projectIDMICIU-AEI/Programa Estatal de generación del conocimiento y fortalecimiento científico y tecnológico del sistema I+D+I y Programa Estatal de I+D+I orientada a los retos de la sociedad/PID2019-105622RB-I00/ES/PROCESAMIENTO DE MOLECULAS PARA CREAR MATERIALES HIBRIDOS ESTRUCTURADOS JERARQUICAMENTE PARA APLICACIONES BIOMEDICAS/ca
dc.subject.udc577ca
dc.identifier.doihttps://doi.org/10.1016/j.supflu.2021.105204ca
dc.contributor.groupProducció de Remugantsca


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Attribution 4.0 International
Except where otherwise noted, this item's license is described as http://creativecommons.org/licenses/by/4.0/
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