Handbook of analysis of oligonucleotides and related products

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Title:

Publication Information:

Boca Raton, FL. : CRC Press, 2011.

Physical Description:

xiv, 497 p. ; 27 cm.

ISBN:

9781439819937

Subject Term:

Oligonucleotides -- Analysis

Added Author:

Bonilla, Jose V.

Srivatsa, Susan

Available:*

Library	Item Barcode	Call Number	Material Type	Item Category 1	Status
Searching... PSZ JB	30000010297207	QP625.O47 H36 2011	Open Access Book	Book	Searching... Unknown

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.

Author Notes

Dr. Jose V. Bonilla's career has been dedicated to the introduction and implementation of cutting-edge analytical technologies such as LC-MS, high-speed gas chromatography, high-speed GPC, online GC, online HPLC, and online near-IR. He has extensive experience in the management of industrial and pharmaceutical analytical laboratories in compliance with regulatory requirements and is the author and coauthor of several peer-reviewed publications.

Dr. G. Susan Srivatsa has more than 20 years of experience in the development of small molecules, proteins, peptides, and oligonucleotides as therapeutics. She has contributed to the successful development of more than 35 DNA and RNA oligonucleotide drug candidates through various stages of clinical development and has published widely in the area of oligonucleotide analysis in peer-reviewed journals.

Hagen Cramer and Kevin J. Finn and Eric HerzbergJim Thayer and Veeravagu Murugaiah and Yansheng WuMing Fai Chan and Ipsita RoymoulikSoheil Pourshahian and Sean M. McCarthyZoltan TimarHuihe Zhu and G. Susan SrivatsaJudy Carmody and Bernhard NollHelen Legakis and Sandra CarrieroDennis P. MichaudBarbara J. MarkleySky Countryman and Jose V. BonillaVeeravagu MurugaiahMichele L. DeRider and Doug Brooks and Gary BurtJose V. BonillaVeeravagu MurugaiahRenee N. Easter and Patrick A. LimbachHüseyin AygünMichael P. MurphyG. Susan Srivatsa

Preface	p. v
Editors	p. vii
Contributors	p. ix
Introduction	p. xi
Chapter 1 Purity Analysis and Impurities Determination by Reversed-Phase High-Performance Liquid Chromatography	p. 1
Chapter 2 Purity Analysis and Impurities Determination by AEX-HPLC	p. 47
Chapter 3 Purity Analysis and Molecular Weight Determination by Size Exclusion HPLC	p. 105
Chapter 4 Analysis of Oligonucleotides by Liquid Chromatography and Mass Spectrometry	p. 137
Chapter 5 Sequence Determination and Confirmation by MS/MS and MALDI-TOF	p. 167
Chapter 6 T m Analysis of Oligonucleotides	p. 219
Chapter 7 Purity and Content Analysis of Oligonucleotides by Capillary Gel Electrophoresis	p. 243
Chapter 8 Bioanalysis of Therapeutic Oligonucleotides Using Hybridization-Based Immunoassay Techniques	p. 265
Chapter 9 Oligonucleotide Assay and Potency	p. 285
Chapter 10 Microbial Analysis: Endotoxin Testing	p. 307
Chapter 11 Analysis of Residual Solvents by Head Space Gas Chromatography	p. 331
Chapter 12 Determination of Extinction Coefficient	p. 351
Chapter 13 Structural Determination by NMR	p. 361
Chapter 14 Infrared Analysis of Oligonucleotides	p. 385
Chapter 15 Stability Indicating Methods for Oligonucleotide Products	p. 403
Chapter 16 Analysis by Hydrophilic Interaction Chromatography	p. 425
Chapter 17 Determination of Base Composition	p. 439
Chapter 18 Analysis of Metals in Oligonucleotides	p. 453
Chapter 19 Regulatory Considerations for the Development of Oligonucleotide Therapeutics	p. 465
Index	p. 487

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Summary

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Author Notes

Table of Contents