Towards quality assessed characterization of nanomaterial: Transfer of validated protocols for size measurement by dynamic light scattering and evaluation of zeta potential by electrophoretic light scattering.

Autor: Varenne F; Institut Galien Paris-Sud, CNRS, Univ. Paris-Sud, University Paris-Saclay, Châtenay-Malabry, France., Rustique E; University Grenoble Alpes, 34054 Grenoble, France; CEA, LETI, MINATEC Campus, 34054 Grenoble, France., Botton J; Univ Paris-Sud, Faculty of Pharmacy, 92296 Châtenay-Malabry, France; INSERM UMR 1153, Epidemiology and Biostatistics Sorbonne Paris Cité Center (CRESS), Team « Early Origin of the Child's Health and Development » (ORCHAD), University Paris Descartes, 94807 Villejuif, France., Coty JB; Institut Galien Paris-Sud, CNRS, Univ. Paris-Sud, University Paris-Saclay, Châtenay-Malabry, France., Lanusse G; Amatsigroup (site Idron), 64320 Idron, France., Ait Lahcen M; Nanobiotix, 75012 Paris, France., Rio L; Nanobiotix, 75012 Paris, France., Zandanel C; Onxeo, 75015 Paris, France., Lemarchand C; Onxeo, 75015 Paris, France., Germain M; Nanobiotix, 75012 Paris, France., Negri L; Amatsigroup (site Idron), 64320 Idron, France., Couffin AC; University Grenoble Alpes, 34054 Grenoble, France; CEA, LETI, MINATEC Campus, 34054 Grenoble, France., Barratt G; Institut Galien Paris-Sud, CNRS, Univ. Paris-Sud, University Paris-Saclay, Châtenay-Malabry, France., Vauthier C; Institut Galien Paris-Sud, CNRS, Univ. Paris-Sud, University Paris-Saclay, Châtenay-Malabry, France. Electronic address: christine.vauthier@u-psud.fr.
Jazyk: angličtina
Zdroj: International journal of pharmaceutics [Int J Pharm] 2017 Aug 07; Vol. 528 (1-2), pp. 299-311. Date of Electronic Publication: 2017 Jun 22.
DOI: 10.1016/j.ijpharm.2017.06.006
Abstrakt: Quality control analysis of nanomaterials has been identified as a major issue to pursue their development in different industrial fields including nanomedicine. One difficulty is the lack of standardized and validated protocols suitable to achieve their characterization. In a previous work, we have developed standardized protocols for the evaluation of the size and zeta potential of nanomaterials based on methods described in the ISO standard and have performed validation of each one. The present work was aimed to transfer these protocols in three independent receiving laboratories. No official guideline was described in the literature to achieve such a transfer. A comparative study for receiving laboratories equipped with the same instrument as the sending laboratory was designed based on the Code of Federal Regulation edited by the Food and Drug Administration. For the receiving laboratory equipped with an instrument working at a different wavelength, a new validation was designed and applied. Corresponding statistical methods were used for the analysis of the results. A successful transfer of the protocols in all receiving laboratories was achieved. All laboratories recorded consistent results applying in blind the protocol of size measurements on two samples of nanomaterials from which included one reference.
(Copyright © 2017 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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