Handbook of Analysis of Oligonucleotides and Related Products 1st Edition by Jose Bonilla, Susan Srivatsa ISBN 1439819947 9781439819944

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Product details:

ISBN 10: 1439819947
ISBN 13: 978-1439819944
Author: Jose V. Bonilla, G. Susan Srivatsa
Handbook of Analysis of Oligonucleotides and Related Products 1st Edition: 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.

 

Handbook of Analysis of Oligonucleotides and Related Products 1st Table of contents:

Chapter 1: Purity Analysis and Impurities Determination by Reversed-Phase High-Performance Liquid Ch

Chapter 2: Purity Analysis and Impurities Determination by AEX-HPLC

Chapter 3: Purity Analysis and Molecular Weight Determination by Size Exclusion HPLC

Chapter 4: Analysis of Oligonucleotides by Liquid Chromatography and Mass Spectrometry

Chapter 5: Sequence Determination and Confirmation by MS/ MS and MALDI-TOF

Chapter 6: Tm Analysis of Oligonucleotides

Chapter 7: Purity and Content Analysis of Oligonucleotides by Capillary Gel Electrophoresis

Chapter 8: Bioanalysis of Therapeutic Oligonucleotides Using Hybridization-Based Immunoassay Techniq

Chapter 9: Oligonucleotide Assay and Potency

Chapter 10: Microbial Analysis : Endotoxin Testing

Chapter 11: Analysis of Residual Solvents by Head Space Gas Chromatography

Chapter 12: Determination of Extinction Coefficient

Chapter 13: Structural Determination by NMR

Chapter 14: Infrared Analysis of Oligonucleotides

Chapter 15: Stability Indicating Methods for Oligonucleotide Products

Chapter 16: Analysis by Hydrophilic Interaction Chromatography

Chapter 17: Determination of Base Composition

Chapter 18: Analysis of Metals in Oligonucleotides

Chapter 19: Regulatory Considerations for the Development of Oligonucleotide Therapeutics

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