Characterization of Nanoparticles Intended for Drug Delivery Table of Contents Part 1. Introduction and Discussion 1. Unique Benefits of Nanotechnology to Drug Delivery and Diagnostics - Scott E. McNeil 2. Challenges for Nanoparticle Characterization - Scott E. McNeil 3. Considerations when submitting nano-therapeutics to FDA/CDER for regulatory review - Katherine Tyner & Nakissa Sadrieh Part 2. Assays to Determine Physical & Chemical Properties 4. Measuring the Hydrodynamic Size of Nanoparticles in Aqueous Media Using Batch-Mode Dynamic Light Scattering - Vincent A. Hackley and Jeffrey D. Clogston 5. Characterization of Nanoparticles by Matrix Assisted Laser Desorption Ionization Time-of-Flight Mass Spectrometry - Uma Ramalinga, Jeffrey D. Clogston, Anil K. Patri, and John T. Simpson 6. Zeta Potential Measurement - Jeffrey D. Clogston and Anil K. Patri 7. Size Measurement of Nanoparticles using Atomic Force Microscopy - Jaroslaw Grobelny, Frank W. DelRio, Namboodirei Pradeep, Doo-In Kim, Vincent A. Hackley and Robert F. Cook 8. Biological Tissue and Cell Culture Specimen Preparation for TEM Nanoparticle Characterization - Kunio Nagashima, Jiwen Zheng, David Parmiter and Anil K. Patri 9. SEM X-ray Microanalysis of Nanoparticles Present in Tissue or Cultured Cell Thin Sections - Jiwen Zheng, Kunio Nagashima, David Parmiter, Jason de la Cruz and Anil K. Patri 10. Detecting and Measuring Free Gadolinium in Nanoparticles for MRI Imaging - Jeffrey D. Clogston and Anil K. Patri 11. Lipid Component Quantitation by Thin Layer Chromatography - Jeffrey D. Clogston & Anil K. Patri Part 3. Assays for Sterility 12. Detection and Quantitative Evaluation of Endotoxin Contamination in Nanoparticle Formulations by LAL-based Assays - Barry W. Neun & Marina A. Dobrovolskaia 13. Analysis of microbial contamination in nanoparticle formulations - Timothy M. Potter & Marina A. Dobrovolskaia Part 4. Assays for In Vitro Detection and Quantitation 14. Gold Nanoparticle Quantitation via Fluorescence in Solution and Cell Culture - Parag Aggarwal & Marina A. Dobrovolskaia 15. Quantitation of Nanoparticles in Serum Matrix by Capillary Electrophoresis - King C. Chan, Timothy D. Veenstra, and Haleem J. Issaq Part 5. In Vitro Assays for Toxicity 16. Evaluation of Cytotoxicity of Nanoparticulate Materials in Porcine Kidney Cells and Human Hepatocarcinoma Cells - Timothy M. Potter and Stephan T. Stern 17. Monitoring Nanoparticle-Treated Hepatacarcinoma Cells for Apoptosis - Timothy M. Potter and Stephan T. Stern 18. Detecting Reactive Oxygen Species in Primary Hepatocytes Treated with Nanoparticles - Stephan T. Stern 19. Assay to Detect Lipid Peroxidation Upon Exposure to Nanoparticles - Timothy M. Potter, Barry W. Neun, and Stephan T. Stern 20. Monitoring Glutathione Homeostasis in Nanoparticle-Treated Hepatocytes - Timothy M. Potter, Barry W. Neun, and Stephan T. Stern 21. Autophagy Monitoring Assay: Qualitative Analysis of MAP LC3-I to II Conversion by Immunoblot - Christopher B. McLeland, Jamie Rodriguez, and Stephan T. Stern 22. Monitoring Lysosomal Activity in Nanoparticle-Treated Cells - Barry W. Neun and Stephan T. Stern Part 6. In Vitro Immunological Assays 23. Method for Analysis of Nanoparticle Hemolytic Properties in Vitro - Barry W. Neun and Marina A. Dobrovolskaia 24. Method for In Vitro Analysis of Nanoparticle Thrombogenic Properties - Barry W. Neun and Marina A. Dobrovolskaia 25. Qualitative Analysis of Total Complement Activation by Nanoparticles - Barry W. Neun and Marina A. Dobrovolskaia 26. Method for Analysis of Nanoparticle Effects on Cellular Chemotaxis - Timothy Potter, Sarah Skoczen & Marina A. Dobrovolskaia 27. In Vitro Analysis of Nanoparticle Uptake by Macrophages Using Chemiliuminescence - Timothy Potter, Sarah Skoczen & Marina A. Dobrovolskaia
