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Handbook of Analysis of Oligonucleotides and Related Products

Edited by: Jose V. Bonilla , G. Susan Srivatsa

Print publication date:  February  2011
Online publication date:  February  2011

Print ISBN: 9781439819937
eBook ISBN: 9781439819944
Adobe ISBN:

 Cite  Marc Record

Book description

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 sequencing
  • Purity analysis by chromatographic or electrophoretic methods, including RP-HPLC, AX-HPLC, HILIC, SEC, and CGE
  • Characterization of sequence-related impurities in oligonucleotides by mass spectrometry and chromatography
  • Structure 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 oligonucleotides
  • Accurate determination of assay values
  • Assessment of the overall quality of oligonucleotides, including microbial analysis and determination of residual solvents and heavy metals
  • Strategies for determining the chemical stability of oligonucleotides
  • The use of hybridization techniques for supporting pharmacokinetics and drug metabolism studies in preclinical and clinical development
  • Guidance for the presentation of relevant analytical information towards meeting current regulatory expectations for oligonucleotide therapeutics

This resource provides a practical guide for applying state-of-the-art analytical techniques in research, development, and manufacturing settings.

Table of contents

Chapter  1:  Purity Analysis and Impurities Determination by Reversed-Phase High-Performance Liquid Chromatography Download PDF
Chapter  2:  Purity Analysis and Impurities Determination by AEX-HPLC Download PDF
Chapter  3:  Purity Analysis and Molecular Weight Determination by Size Exclusion HPLC Download PDF
Chapter  4:  Analysis of Oligonucleotides by Liquid Chromatography and Mass Spectrometry Download PDF
Chapter  5:  Sequence Determination and Confirmation by MS/MS and MALDI-TOF Download PDF
Chapter  6:  T Analysis of Oligonucleotides Download PDF
Chapter  7:  Purity and Content Analysis of Oligonucleotides by Capillary Gel Electrophoresis Download PDF
Chapter  8:  Bioanalysis of Therapeutic Oligonucleotides Using Hybridization-Based Immunoassay Techniques Download PDF
Chapter  9:  Oligonucleotide Assay and Potency Download PDF
Chapter  10:  Microbial Analysis: Endotoxin Testing  Download PDF
Chapter  11:  Analysis of Residual Solvents by Head Space Gas Chromatography Download PDF
Chapter  12:  Determination of Extinction Coefficient Download PDF
Chapter  13:  Structural Determination by NMR Download PDF
Chapter  14:  Infrared Analysis of Oligonucleotides Download PDF
Chapter  15:  Stability Indicating Methods for Oligonucleotide Products Download PDF
Chapter  16:  Analysis by Hydrophilic Interaction Chromatography Download PDF
Chapter  17:  Determination of Base Composition Download PDF
Chapter  18:  Analysis of Metals in Oligonucleotides Download PDF
Chapter  19:  Regulatory Considerations for the Development of Oligonucleotide Therapeutics Download PDF
prelims Download PDF
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