Description
Book SynopsisOligonucleotides represent one of the most significant pharmaceutical breakthroughs in recent years, showing great promise as diagnostic and therapeutic agents for malignant tumors, cardiovascular disease, diabetes, viral infections, and many other degenerative disorders. The Handbook of Analysis of Oligonucleotides and Related Products is an essential reference manual on the practical application of modern and emerging analytical techniques for the analysis of this unique class of compounds. A strong collaboration among thirty leading analytical scientists from around the world, the book provides readers with a comprehensive overview of the most commonly used analytical techniques and their advantages and limitations in assuring the identity, purity, quality, and strength of an oligonucleotide intended for therapeutic use.
Topics discussed include:
- Strategies for enzymatic or chemical degradation of chemically modified oligonucleotides to
Trade Review
This is a unique resource for guiding the analysis of oligonucleotide-based drug products. No other single source provides such a comprehensive overview of the necessary analytical techniques that assess the qualitative characteristics of oligonucleotides intended for pharmaceutical use.
—Rachel R Chennault, Ph.D.(American College of Clinical Pharmacy), in Doody's Notes
Table of Contents
Purity Analysis and Impurities Determination by Reversed-Phase High- Performance Liquid Chromatography. Purity Analysis and Impurities Determination by AEX-HPLC. Purity Analysis and Molecular Weight Determination by Size Exclusion HPLC Analysis. Analysis of Oligonucleotides by Liquid Chromatography—Mass Spectrometry. Sequence Determination and Confirmation by MS/M S and MALDI-TOF. Tm Analysis of Oligonucleotides. Purity and Content Analysis of Oligonucleotides by Capillary Gel Electrophoresis. Bioanalysis of Therapeutic Oligonucleotides Using Hybridization-Based Immunoassay Techniques. Oligonucleotide Assay and Potency. Microbial Analysis: Endotoxin Testing. Analysis of Residual Solvents by Head Space Gas Chromatography. Determination of Extinction Coefficient. Structural Determination by NMR. Infrared Analysis of Oligonucleotides. Stability Indicating Methods for Oligonucleotide Products. Analysis by Hydrophilic Interaction Chromatography. Determination of Base Composition. Analysis of Metals in Oligonucleotides. Regulatory Considerations for the Development of Oligonucleotide Therapeutics.
