"This book details the latest advances in methodology for determining physiochemical, immunological, and toxicological properties of nanoparticles for use in medicine. ... The chapter author are the very qualified experts responsible for developing the majority of the protocols for nanoparticle characterization ... . serves an audience of researchers in the scientific community, pharmaceutical drug developers, and regulatory agencies. ... This is an excellent resource for understanding the unique challenges in the development and in vitro evaluation of nanoparticle-based therapeutic agents." (Rachel R. Chennault, Doody's Review Service, June, 2011)
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
In recent years, there have been many exciting breakthroughs in the application of nanotechnology to medicine. In Characterization of Nanoparticles Intended for Drug Delivery, expert researchers explore the latest advances in the field, providing a set of basic methods for the characterization of nanomaterials for medical use. Chapters provide methods to characterize the physiochemical properties (size, aggregation, and surface chemistry) and in vitro immunological and biological characteristics of nanomaterials. Composed in the highly successful Methods in Molecular Biology™ series format, each chapter contains a brief introduction, step-by-step methods, a list of necessary materials, and a Notes section which shares tips on troubleshooting and avoiding known pitfalls.
Comprehensive and informative, Characterization of Nanoparticles Intended for Drug Delivery is an essential survey of methods that are crucial to the preclinical characterization of nanomedicines.