Approaches to the conformational analysis of biopharmaceuticals

The activity of many biopharmaceutical polymers is dependent on conformation, and the next several years will see increased interest in the conformational analysis of these polymers resulting from the development of biosimilar or "follow-on" biological products. While a wide variety of approaches to analysis exists, finding the most viable ones would be much easier with a consolidated reference that details the benefits and cost of each approach, with an emphasis on real results and real products.

Explores the Growing Role of Conformational Analysis in Comparing Generic Biopharmaceuticals

Approaches to the Conformational Analysis of Biopharmaceuticals gathers the most useful techniques and methods into a single volume, putting the greatest emphasis on those approaches that have proven the most fruitful. Rather than cover specific uses of techniques in detail, this book provides commercial biotechnologists and researchers with the information and references they need to make good choices about the technology they choose to use. With a large number of references that direct readers to primary source material, it includes studies drawn from the gamut of current literature, covering physical methods, such as differential scanning calorimetry, light scanning, and analytical ultracentrifugation. It also addresses chemical methods, such as hydrogen-deuterium exchange and trace labeling, along with infrared, ultraviolet, and Raman spectroscopy.

Written by Roger Lundblad, a true pioneer in protein science, this volume supplies the necessary information researchers need to access when deciding on the most cost-effective approach, including:

Comparability of biopharmaceuticals Characterization of follow-on biologics Quality attributes of protein biopharmaceuticals Confrontational analysis of biopharmaceutical products

With a clear focus on relevant commercial biotechnology, this book belongs on the shelves of those serious researchers who are paving the way for the next generation of biopharmaceutical polymers.

Author Notes

After postdoctoral work at Rockefeller University, New York, Dr. Roger L. Lundblad joined the faculty of the University of North Carolina at Chapel Hill in 1968. He joined the Hyland division of Baxter Healthcare in 1990. Currently, he is an independent consultant and biotechnology writer based in Chapel Hill, North Carolina. He is an adjunct professor of pathology at the University of North Carolina at Chapel Hill and an editor in chief of the Internet Journal of Genomics and Proteomics.

Series Preface	p. ix
Preface	p. xi
Author	p. xiii
Chapter 1 Introduction to Biopharmaceutical Conformational Analysis: Issues and Methods	p. 1
References	p. 5
Chapter 2 Comparability of Biotechnological/Biological Products and Biological Generics	p. 19
References	p. 29
Chapter 3 Application of Native Electrophoresis for the Study of Protein Conformation	p. 37
References	p. 41
Chapter 4 Affinity Chromatography Including Hydrophobic Interaction Chromatography in the Study of Biopolymer Conformation	p. 49
References	p. 64
Chapter 5 Size-Exclusion Chromatography and Biomolecular Conformation	p. 77
References	p. 83
Chapter 6 Use of Analytical Ultracentrifugation to Study Biomolecular Conformation	p. 87
References	p. 91
Chapter 7 Use of Differential Scanning Calorimetry to Measure Conformational Change in Proteins and Other Biomacromolecules	p. 97
References	p. 104
Chapter 8 Light Scattering and Biomacromolecular Conformation	p. 111
References	p. 121
Chapter 9 Use of Luminescence to Measure Conformational Change in Biopharmaceuticals with Emphasis on Protein and Protein Drug Products	p. 131
References	p. 150
Chapter 10 Near-Infrared Spectroscopy and Macromolecular Conformation	p. 163
References	p. 166
Chapter 11 Use of Mid-Infrared and Fourier Transform Infrared Spectroscopy to Study Conformation of Biomacromolecules	p. 175
References	p. 183
Chapter 12 Use of Raman Spectroscopy to Evaluate Biopharmaceutical Conformation	p. 191
References	p. 193
Chapter 13 Use of U V-VIS Spectrophotometry for the Characterization of Biopharmaceutical Products	p. 197
References	p. 201
Chapter 14 Use of Optical Rotatory Dispersion and Circular Dichroism to Study Therapeutic Biomacromolecule Conformation	p. 207
References	p. 210
Chapter 15 Use of Nuclear Magnetic Resonance for the Characterization of Biotherapeutic Products	p. 215
References	p. 219
Chapter 16 Use of Chemical Probes for the Study of Protein Conformation	p. 223
References	p. 234
Chapter 17 Use of Hydrogen Exchange in the Study of Biopharmaceutical Conformation	p. 241
References	p. 245
Chapter 18 Use of Chemical Modification for the Conformational Analysis of Biopharmaceuticals	p. 251
References	p. 281
Chapter 19 Use of Immunology to Characterize Biopharmaceutical Conformation	p. 299
References	p. 307
Chapter 20 Use of Limited Proteolysis to Study the Conformation of Proteins of Biotechnological Interest	p. 317
References	p. 321
Chapter 21 Other Technologies for the Characterization of Conformational Change in Biopharmaceuticals	p. 327
Crystallographic Analysis p. 327
Small-Angle Neutron Scattering and Small-Angle X-Ray Scattering	p. 329
Equilibrium Dialysis	p. 330
Enzyme Kinetics	p. 330
References	p. 333
Chapter 22 Development of an Experimental Approach for the Study of the Conformation of a Biological Therapeutic Product	p. 341
References	p. 344
Index	p. 349

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Table of Contents