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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 gov http ncl cancer gov

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

slide2

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
slide3

Nanotechnology CharacterizationLaboratory (NCL)

NCL Concept of Operations:

FDA

NCL is a formal collaboration among NCI, FDA and NIST

a different approach is needed

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

influence of surface chemistry charge

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.

slide6

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

summary
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