Handbook of Analysis of Oligonucleotides and Related Products

Oligonucleotides 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 toward mass spectrometric sequencingPurity analysis by chromatographic or electrophoretic methods including RP-HPLC AX-HPLC HILIC SEC and CGECharacterization of sequence-related impurities in oligonucleotides by mass spectrometry and chromatographyStructure elucidation by spectroscopic methods (IR NMR MS) as well as base composition and thermal melt analysis (Tm)Approaches for the accurate determination of molar extinction coefficient of oligonucleotidesAccurate determination of assay valuesAssessment of the overall quality of oligonucleotides including microbial analysis and determination of residual solvents and heavy metalsStrategies for determining the chemical stability of oligonucleotidesThe use of hybridization techniques for supporting pharmacokinetics and drug metabolism studies in preclinical and clinical developmentGuidance for the presentation of relevant analytical information towards meeting current regulatory expectations for oligonucleotide therapeuticsThis resource provides a practical guide for applying state-of-the-art analytical techniques in research development and manufacturing settings.