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)