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.
Table of Contents
Introduction to Biopharmaceutical Conformational Analysis: Issues and Methods
Comparability of Biotechnological/Biological Products and Biological Generics
Application of Native Electrophoresis for the Study of Protein Conformation
Affinity Chromatography Including Hydrophobic Interaction
Chromatography in the Study of Biopolymer Conformation
Size-Exclusion Chromatography and Biomolecular Conformation
Use of Analytical Ultracentrifugation to Study Biomolecular Conformation
Use of Differential Scanning Calorimetry to Measure Conformational Change in Proteins and Other Biomacromolecules
Light Scattering and Biomacromolecular Conformation
Use of Luminescence to Measure Conformational Change in Biopharmaceuticals with Emphasis on Protein and Protein Drug Products
Near-Infrared Spectroscopy and Macromolecular Conformation
The Use of Mid-Infrared and Fourier Transform Infrared Spectroscopy to Study Conformation of Biomacromolecules
Use of Raman Spectroscopy to Evaluate Biopharmaceutical Conformation
Use of UV-VIS Spectrophotometry for the Characterization of Biopharmaceutical Products
Use of Optical Rotatory Dispersion and Circular Dichroism to Study Therapeutic Biomacromolecule Conformation
Use of Nuclear Magnetic Resonance for the Characterization of Biotherapeutic Products
Use of Chemical Probes for the Study of Protein Conformation
Use of Hydrogen Exchange in the Study of Biopharmaceutical Conformation
Use of Chemical Modification for the Conformational Analysis of Biopharmaceuticals
Use of Immunology to Characterize Biopharmaceutical Conformation
Use of Limited Proteolysis to Study the Conformation of Proteins of Biotechnology Interest
Other Technologies for the Characterization of Conformational Change in Biopharmaceuticals
Development of an Experimental Approach for the Study of the Conformation of a Biological Therapeutic Product
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.
"Lundblad (pathology, U. of North Carolina at Chapel Hill) provides coverage of the range of technology used for the conformational analysis of biopharmaceutical polymers, intending to provide sufficient information and extensive references to establish the basis for the selection of a specific experimental approach that would be most cost-effective in the study of biopolymer conformation. Technologies addressed include native electrophoresis, affinity chromatography, size-exclusion chromatography, analytical ultracentrifugation, differential scanning calorimetry, light scattering, luminescence, near-infrared spectroscopy, mid-infrared and Fourier transform infrared spectroscopy, Raman spectroscopy, UV-VIS spectroscopy, optical rotatory dispersion and circular dichroism, nuclear magnetic resonance, chemical probes, hydrogen exchange, chemical modification,. immunology, and limited proteolysis"
—2010 Book News Inc., Portland, Oregon
"Without any hesitation, I recommend this book to any researcher involved in the analysis of conformation and stability of biotechnology products (not necessarily limited to biopharmaceuticals)."
—Igor A Kaltashov. Future Science