A general resource for industrial scientists to guide them in implementing biophysical methodologies for analysis of biopharmaceutical proteins.
List of Contributors About the Editors Preface List of
Abbreviations and Symbols
I: Proteins and Biophysical Characterization in the
Biopharmaceutical Industry Chapter 1 - The Complexity of Protein
Structure and the Challenges it Poses in Developing
Biopharmaceuticals (Steven A. Berkowitz, Damian J. Houde) Chapter 2
- Biophysical Characterization and Its Role in the
Biopharmaceutical Industry (Damian J. Houde, Steven A. Berkowitz)
Chapter 3 - Biopharmaceutical Industry's Biophysical Toolbox
(Damian J. Houde, Steven A. Berkowitz)
II: The Selected Biophysical Tools in the Biopharmaceutical
Industry Chapter 4 - An Introduction and Hierarchical Organization
of the Biophysical Tool in Section II (Damian J. Houde, Steven A.
Berkowitz) Chapter 5 - The Value of UV, Fluorescence, and FTIR
Spectroscopy in Biopharmaceutical Development (Mark Brader) Chapter
6 - Circular Dichroism Spectroscopy for Protein Characterization:
Biopharmaceutical Applications (A.J. Miles, B.A. Wallace) Chapter 7
- Size-Exclusion Chromatograph (SEC) in Biopharmaceutical Process
Development (Steven A. Berkowitz, Damian J. Houde) Chapter 8 -
Scattering Techniques for the Characterization of
Biopharmaceuticals, Pages 171-209, Lee Makowski, Steven A.
Berkowitz, Damian J. Houde Chapter 9 - Characterizing
Biopharmaceuticals using Analytical Ultracentrifugation (Steven A.
Berkowitz, John S. Philo) Chapter 10 - Subvisible and Visible
Particle Analysis in Biopharmaceutical Research and Development,
Pages 261-286, Andrea Hawe, Sarah Zölls, Angelika Freitag, John F.
Carpenter Chapter 11 - Differential Scanning Calorimetry in the
Biopharmaceutical Sciences (Stephen J. Demarest, Verna Frasca)
Chapter 12 - Biophysical Mass Spectrometry for Biopharmaceutical
Process Development: Focus on Hydrogen/Deuterium Exchange (George
M. Bou-Assaf, Alan G. Marshall) Chapter 13 - One- and
Two-Dimensional NMR Techniques for Biopharmaceuticals (Yves Aubin,
Daron I. Freedberg, David A. Keire)
III: Concluding Remarks on the Biophysical Characterization of
Biopharmaceuticals Chapter 14 - Biophysical Characterization: An
Integral Part of the “Totality of the Evidence Concept (Damian J.
Houde, Steven A. Berkowitz)
Index
Damian J. Houde is Professor at the Department of Chemistry and
Chemical Biology at the Northeastern University in Boston, MA. He
teaches undergraduate and graduate level chemistry, biochemistry
courses, and bioanalytical biochemistry. Further he is scientist,
analytical development at Biogen Idec, Inc. in Cambridge, MA. He
performs detailed biochemical and biophysical characterization of
protein biopharmaceuticals (primarily
monoclonal antibodies and Fc-fusion proteins) for structure
activity relationship studies, investigates the conformation,
dynamics, and interactions (epitope mapping) of protein
biopharmaceuticals, with hydrogen-deuterium exchange mass
spectrometry, assesses, develops, and evaluates new biochemical and
biophysical protein characterization tools, coordinates and manages
external academic (Northeastern University and University of Mass
at Amherst) and internal research collaborations, manages and
maintains mass spectrometry instrumentation, and conducts method
transfers to QC. In 2009 he received the Douglas and Irena DeVivo
Award (Northeastern University), in 2008 the Biogen IDEC Technology
Investment Award, in 2008 the Biogen IDEC Technology Investment
Award, Outstanding presentation, and in 2007 the Biogen IDEC
Technology Investment Award Steven A. Berkowitz is a principal
investigator in the department of analytical development at Biogen
Idec, Inc. in Cambridge MA. His technical areas of expertise are
concentrated in the separation sciences and the physical sciences
associated with the characterization of biopolymers and synthetic
polymers where he has over 40 peer reviewed publication and has
presented numerous talks and posters at a wide range of technical
meetings. Much of Dr. Berkowitz’s work has centered on assessing
the physico-chemical properties, micro-heterogeneity and
aggregation properties of biopharmaceuticals using light
scattering, analytical ultracentrifugation, chromatography,
electrophoresis, and various forms of spectroscopy. His present
responsibilities are now focused on providing biophysical
information on the higher-order structure and structural dynamics
of biopharmaceuticals and the development and evaluation of
analytical tools such as H/DX-MS and NMR to support this area. Dr.
Berkowitz received a B.S. degree in Biology from Fairleigh
Dickinson University and a Ph.D. degree in Biochemistry from New
York University. He then spent several years as a post-doctoral
fellow at Yale University and the NIH. After his post-doctoral work
Dr. Berkowitz held various positions at Celanese Research Company,
J.T. Baker, and Lederle Laboratories before taking his present
position at Biogen Idec.
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