Application of Quality by Design to the robust preparation of a liposomal GLA formulation by DELOS-susp method.
J Supercrit Fluids
; 173: 105204, 2021 Jul.
Article
em En
| MEDLINE
| ID: mdl-34219919
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
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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