Characterization of Nanoparticles Intended for Drug Delivery

• Unique Benefits of Nanotechnology to Drug Delivery and Diagnostics.- Challenges for Nanoparticle Characterization.- Considerations when submitting nano-therapeutics to FDA/CDER for regulatory review.- Measuring the Hydrodynamic Size of Nanoparticles in Aqueous Media Using Batch-Mode Dynamic Light Scattering.- Characterization of Nanoparticles by Matrix Assisted Laser Desorption Ionization Time-of-Flight Mass Spectrometry.- Zeta Potential Measurement.- Size Measurement of Nanoparticles using Atomic Force Microscopy.- Biological Tissue and Cell Culture Specimen Preparation for TEM Nanoparticle Characterization.– SEM X-ray Microanalysis of Nanoparticles Present in Tissue or Cultured Cell Thin Sections.- Detecting and Measuring Free Gadolinium in Nanoparticles for MRI Imaging.- Lipid Component Quantitation by Thin Layer Chromatography.- Detection and Quantitative Evaluation of Endotoxin Contamination in Nanoparticle Formulations by LAL-based Assays.- Analysis of microbial contamination in nanoparticle formulations.- Gold Nanoparticle Quantitation via Fluorescence in Solution and Cell Culture.- Quantitation of Nanoparticles in Serum Matrix by Capillary Electrophoresis.- Evaluation of Cytotoxicity of Nanoparticulate Materials in Porcine Kidney Cells and Human Hepatocarcinoma Cells.- Monitoring Nanoparticle-Treated Hepatacarcinoma Cells for Apoptosis – Detecting Reactive Oxygen Species in Primary Hepatocytes Treated with Nanoparticles.- Assay to Detect Lipid Peroxidation Upon Exposure to Nanoparticles.- Monitoring Glutathione Homeostasis in Nanoparticle-Treated Hepatocytes.- Autophagy Monitoring Assay: Qualitative Analysis of MAP LC3-I to II Conversion by Immunoblot.- Monitoring Lysosomal Activity in Nanoparticle-Treated Cells.- Method for Analysis of Nanoparticle Hemolytic Properties in Vitro.- Method for In Vitro Analysis of Nanoparticle Thrombogenic Properties.- Qualitative Analysis of Total Complement Activation by Nanoparticles.- Method for Analysis ofNanoparticle Effects on Cellular Chemotaxis.- In Vitro Analysis of Nanoparticle Uptake by Macrophages Using Chemiliuminescence.

From the reviews: "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)