Handbook of Analysis of Oligonucleotides and Related Products

ISBN-13: 9781439819937 / Angielski / Twarda / 2011 / 497 str.

Jose V. Bonilia; Hagen Cramer

Opis

A first-of-its-kind handbook, this text covers all the analytical techniques and methods commonly employed with oligonucleotides. With contributions from experts in the field, this handbook presents comprehensive coverage for analytical chemists, biochemists, biotechnologists, molecular biologists, and geneticists on the latest analytical technologies currently available. Topics covered include purity determination by HPLC, molecular weight determination, determination of hygroscopicity, analysis of bioburden, and analyses of ionic species by ion chromatography. A chapter on PAT and coverage of bioanalytical techniques is also included, and illustrations of analytical techniques and outputs are presented to aid with comprehension.

Recenzje

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 

Spis treści

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.