Are existing standard methods suitable for the evaluation of nanomedicines: Some case studies
| Description | |
| Date | |
| Authors | Gioria S., Caputo F., Urbán P., Maguire C.M., Bremer-Hoffmann S., Prina-Mello A., Calzolai L., Mehn D. |
| Year | 2018-0054 |
| Source-Title | Nanomedicine |
| Affiliations | European Commission, Joint Research Center (JRC), Directorate for Health, Consumers and Reference Materials, Via Enrico Fermi 2749, Ispra, VA, Italy, Univ. Grenoble Alpes, Grenoble, France, CEA, LETI, Minatec Campus, Grenoble, France, Laboratory for Biological Characterization of Advanced Materials (LBCAM), Department of Clinical Medicine, Trinity Translational Medicine Institute (TTMI), School of Medicine, Trinity College Dublin, I-Dublin-8, Ireland, AMBER Center and CRANN Institute, Trinity College Dublin, I-Dublin-2, Ireland |
| Abstract | The use of nanotechnology in medical products has been demonstrated at laboratory scale, and many resulting nanomedicines are in the translational phase toward clinical applications, with global market trends indicating strong growth of the sector in the coming years. The translation of nanomedicines toward the clinic and subsequent commercialization may require the development of new or adaptation of existing standards to ensure the quality, safety and efficacy of such products. This work addresses some identified needs, and illustrates the shortcomings of currently used standardized methods when applied to medical-nanoparticles to assess particle size, drug loading, drug release and in vitro safety. Alternative physicochemical, and in vitro toxicology methods, with the potential to qualify as future standards supporting the evaluation of nanomedicine are provided. © 2018 2018 JRC. |
| Author-Keywords | analytical ultracentrifugation, cytotoxicity, drug release, field flow fractionation, high content screening, nanomedicine, nanoparticle tracking analysis, particle size distribution, regulatory, safety assessment |
| Index-Keywords | |
| ISSN | 17435889 |
| Link | Link |