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Application of Quality by Design to the robust preparation of a liposomal GLA formulation by DELOS-susp method.
Merlo-Mas, Josep; Tomsen-Melero, Judit; Corchero, José-Luis; González-Mira, Elisabet; Font, Albert; Pedersen, Jannik N; García-Aranda, Natalia; Cristóbal-Lecina, Edgar; Alcaina-Hernando, Marta; Mendoza, Rosa; Garcia-Fruitós, Elena; Lizarraga, Teresa; Resch, Susanne; Schimpel, Christa; Falk, Andreas; Pulido, Daniel; Royo, Miriam; Schwartz, Simó; Abasolo, Ibane; Pedersen, Jan Skov; Danino, Dganit; Soldevila, Andreu; Veciana, Jaume; Sala, Santi; Ventosa, Nora; Córdoba, Alba.
Afiliação
  • Merlo-Mas J; Nanomol Technologies S.L., 08193 Cerdanyola del Vallès, Spain.
  • Tomsen-Melero J; Nanomol Technologies S.L., 08193 Cerdanyola del Vallès, Spain.
  • Corchero JL; Institut de Ciència de Materials de Barcelona, ICMAB-CSIC, 08193 Bellaterra, Spain.
  • González-Mira E; Centro de Investigación Biomédica en Red - Bioingeniería, Biomateriales y Nanomedicina (CIBER-BBN), 28029 Madrid, Spain.
  • Font A; Centro de Investigación Biomédica en Red - Bioingeniería, Biomateriales y Nanomedicina (CIBER-BBN), 28029 Madrid, Spain.
  • Pedersen JN; Institut de Biotecnologia i Biomedicina (IBB-UAB), 08193 Cerdanyola del Vallès, Spain.
  • García-Aranda N; Institut de Ciència de Materials de Barcelona, ICMAB-CSIC, 08193 Bellaterra, Spain.
  • Cristóbal-Lecina E; Centro de Investigación Biomédica en Red - Bioingeniería, Biomateriales y Nanomedicina (CIBER-BBN), 28029 Madrid, Spain.
  • Alcaina-Hernando M; Leanbio S.L., 08028 Barcelona, Spain.
  • Mendoza R; Department of Chemistry and Interdisciplinary Nanoscience Center (iNANO), Aarhus University, 8000, Aarhus, Aarhus C Denmark.
  • Garcia-Fruitós E; Centro de Investigación Biomédica en Red - Bioingeniería, Biomateriales y Nanomedicina (CIBER-BBN), 28029 Madrid, Spain.
  • Lizarraga T; Functional Validation and Preclinical Research, Drug Delivery & Targeting, CIBBIM-Nanomedicina, Vall d'Hebron Institute of Research (VHIR), Universitat Autònoma de Barcelona (UAB), 08035 Barcelona, Spain.
  • Resch S; Centro de Investigación Biomédica en Red - Bioingeniería, Biomateriales y Nanomedicina (CIBER-BBN), 28029 Madrid, Spain.
  • Schimpel C; Institut de Química Avançada de Catalunya (IQAC-CSIC), 08034 Barcelona, Spain.
  • Falk A; Nanomol Technologies S.L., 08193 Cerdanyola del Vallès, Spain.
  • Pulido D; Centro de Investigación Biomédica en Red - Bioingeniería, Biomateriales y Nanomedicina (CIBER-BBN), 28029 Madrid, Spain.
  • Royo M; Institut de Biotecnologia i Biomedicina (IBB-UAB), 08193 Cerdanyola del Vallès, Spain.
  • Schwartz S; Centro de Investigación Biomédica en Red - Bioingeniería, Biomateriales y Nanomedicina (CIBER-BBN), 28029 Madrid, Spain.
  • Abasolo I; Institut de Biotecnologia i Biomedicina (IBB-UAB), 08193 Cerdanyola del Vallès, Spain.
  • Pedersen JS; Leanbio S.L., 08028 Barcelona, Spain.
  • Danino D; BioNanoNet Forschungsgesellschaft mbH, 8010 Graz, Austria.
  • Soldevila A; BioNanoNet Forschungsgesellschaft mbH, 8010 Graz, Austria.
  • Veciana J; BioNanoNet Forschungsgesellschaft mbH, 8010 Graz, Austria.
  • Sala S; Centro de Investigación Biomédica en Red - Bioingeniería, Biomateriales y Nanomedicina (CIBER-BBN), 28029 Madrid, Spain.
  • Ventosa N; Institut de Química Avançada de Catalunya (IQAC-CSIC), 08034 Barcelona, Spain.
  • Córdoba A; Centro de Investigación Biomédica en Red - Bioingeniería, Biomateriales y Nanomedicina (CIBER-BBN), 28029 Madrid, Spain.
J Supercrit Fluids ; 173: 105204, 2021 Jul.
Article em En | MEDLINE | ID: mdl-34219919
Palavras-chave
BCA, Bicinchoninic acid assay; CMA, Critical Material Attributes; CO2, Carbon dioxide; CPP, Critical Process Parameters; CQA, Critical Quality Attribute; Chol, Cholesterol; Chol-PEG400-RGD, Cholesterol pegylated with arginyl­glycyl­aspartic (RGD) acid peptide; CoA, Certificate of Analysis; Cryo-TEM, Cryogenic Transmission Electron Microscopy; DELOS; DELOS-susp, Depressurization of an Expanded Liquid Organic Solution into aqueous solution; DLS, Dynamic Light Scattering; DMSO, Dimethyl sulfoxide; DPPC, 1,2-Dipalmitoyl-sn-glycero-3-phosphocholine; DoE, Design of Experiments; EA, Enzymatic Activity; EE, Entrapment Efficiency; EHS, Environment, Health and Safety; EMA, European Medicines Agency; ERT, Enzyme Replacement Therapy; EtOH, Ethanol; FDA, Food and Drug Administration; Fabry disease; GLA, α-galactosidase A enzyme; H2O, Water; HPLC, High Performance Liquid Chromatography; ICH, Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; LSD, Lysosomal storage disorders; MKC, Myristalkonium chloride; N2, Nitrogen; NTA, Nanoparticle Tracking Analysis; PEG, Polyethylene Glycol; PIC, Pressure Indicator Controller; PLS, Partial Least Squares; PdI, Polydispersity Index; Protein-loaded liposomes; Pw, Working pressure; QbD, Quality by Design; Quality by Design; RGD, Arginine-Glycine-Aspartic acid; S-MLS, Static Multiple Light Scattering; SAXS, Small-Angle X-ray Scattering; SDS-PAGE, Sodium Dodecyl Sulfate Polyacrylamide Gel Electrophoresis; SbD, Safe by Design; Scale-up; TFF, Tangential Flow Filtration; TGX, Trys-Glycine eXtended; TIC, Temperature Indicator Controller; TSI, Turbiscan Stability Index; Tw, Working temperature; USP, United States Pharmacopeia; XCO2, Carbon dioxide molar fraction; fsingle, Ratio of monolayered liposomes; nanoGLA, GLA-loaded nanoliposomes; α-galactosidase

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Idioma: En Revista: J Supercrit Fluids Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Espanha

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Idioma: En Revista: J Supercrit Fluids Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Espanha