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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.

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Scott McNeil, Ph.D. ncl@ncifcrf nclncer

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  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

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