scott mcneil, ph.d. ncl@ncifcrf nclncer
DESCRIPTION
Public Meeting on Nanotechnology Materials in FDA-Regulated Products October 10, 2006. Scott McNeil, Ph.D. [email protected] http://ncl.cancer.gov. Preclinical Characterization of Nanoparticles. Cancer Nanotechnology Program. - PowerPoint PPT PresentationTRANSCRIPT
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Scott McNeil, [email protected]
http://ncl.cancer.gov
Preclinical Characterization of Nanoparticles
Public Meeting on Nanotechnology Materials in FDA-Regulated Products
October 10, 2006
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• 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
Cancer Nanotechnology Program
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NCL is a formal collaboration among NCI, FDA and NIST
FDA
NCL Concept of Operations:
Nanotechnology CharacterizationLaboratory (NCL)
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• Elemental analysis• Mass• NMR• UV-Vis• IR• HPLC• GC• Polarimetry
Small moleculesPhysicochemical
Parameters
• Composition• Physical properties• Chemical properties• Identification • Quality• Purity• Stability
Same parameters – different/additional characterization methods
A Different Approach Is Needed
• Microscopy (AFM,TEM, SEM)
• Light scattering(Static, Dynamic)
• SEC, FFF• Electrophoresis
(CE, PAGE)• Zeta sizer• Fluorimetry
Nanomaterials
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LLC-PK1 24 hr CytotoxicityMTT Viability Assay
0
20
40
60
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100
120
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Dose (mg/mL)
% C
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G4 PEG
G6 PEG
G6 OH
G6 NH2
G6 CO2H
Influence of Surface Chemistry/Charge
0
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Dendrimer
NCL is working with FDA to identify parameters that contribute to biocompatibility and toxicity.
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No Incubation + Serum
50nm
30nm
50nm
30nm
Particle Size in a Biological Context
Characterization should be interdisciplinary, and conducted under biologically relevant
conditions
DLS Size:
DLS Size:DLS Size:
DLS Size:
56nm
82nm
36nm
113nm
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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 [email protected](301) 846-6939 http://ncl.cancer.gov