html5-img
1 / 7

Scott McNeil, Ph.D. ncl@ncifcrf nclncer

Public Meeting on Nanotechnology Materials in FDA-Regulated Products October 10, 2006. Scott McNeil, Ph.D. ncl@ncifcrf.gov http://ncl.cancer.gov. Preclinical Characterization of Nanoparticles. Cancer Nanotechnology Program.

angelo
Download Presentation

Scott McNeil, Ph.D. ncl@ncifcrf nclncer

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Public Meeting on Nanotechnology Materials in FDA-Regulated Products October 10, 2006 Scott McNeil, Ph.D. ncl@ncifcrf.gov http://ncl.cancer.gov Preclinical Characterization of Nanoparticles

  2. Cancer Nanotechnology Program • Managed by Office of Technology and Industrial Relations (OTIR), NCI • Launched on Sept 13th, 2004 • Website: http://nano.cancer.gov • Consensus among cancer researchers that significant obstacles must be overcome in order to translate ‘nano’ into the clinical realm • Critical lack of available standards • 1st principles characterization • Perceived regulatory uncertainty

  3. Nanotechnology CharacterizationLaboratory (NCL) NCL Concept of Operations: FDA NCL is a formal collaboration among NCI, FDA and NIST

  4. Nanomaterials • Microscopy (AFM,TEM, SEM) • Light scattering(Static, Dynamic) • SEC, FFF • Electrophoresis (CE, PAGE) • Zeta sizer • Fluorimetry A Different Approach Is Needed • Physicochemical Parameters • Composition • Physical properties • Chemical properties • Identification • Quality • Purity • Stability Small molecules • Elemental analysis • Mass • NMR • UV-Vis • IR • HPLC • GC • Polarimetry Same parameters – different/additional characterization methods

  5. 30 25 20 % Hemolysis 15 10 5 0 PEG PL G6-OH G6-NH2 Influence of Surface Chemistry/Charge G4 PEG LLC-PK1 24 hr Cytotoxicity G6 PEG MTT Viability Assay G6 OH 140 G6 NH2 120 G6 CO2H 100 Dendrimer 80 % Control 60 40 20 0 0.0001 0.001 0.01 0.1 1 10 Dose (mg/mL) NCL is working with FDA to identify parameters that contribute to biocompatibility and toxicity.

  6. Particle Size in a Biological Context No Incubation + Serum DLS Size: 50nm DLS Size: 50nm 56nm 113nm Characterization should be interdisciplinary, and conducted under biologically relevant conditions DLS Size: DLS Size: 30nm 30nm 36nm 82nm

  7. Summary • NCL is a collaboration among NCI, FDA and NIST • Nanomaterials intended for medical applications may require an alternate toolset for characterization • Preclinical testing indicates that multiple physico-chemical parameters influence biocompatibility and toxicity • Key parameters include size, surface chemistry, and charge • Elucidation of structure activity relationships requires an interdisciplinary approach • Data does not support generalizations Contact Info: Scott E. McNeil ncl@ncifcrf.gov (301) 846-6939 http://ncl.cancer.gov

More Related