Biophysical Methods for Biotherapeutics

Discovery and Development Applications
Herausgegeben von Das, Tapan K.

• Gebundenes Buch

Produktbeschreibung

With a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development.

Helps formulation and analytical scientists in pharma and biotech better understand and use biophysical methods
Chapters organized according to the sequential nature of the drug development process
Helps formulation, analytical, and bioanalytical scientists in pharma and biotech better understand and usestrengths and limitations of biophysical methods
Explains how to use biophysical methods, the information obtained, and what needs to be presented in a regulatory filing, assess impact on quality and immunogenicity
With a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development.

Produktdetails

• Verlag: Wiley & Sons
• 1. Auflage
• Seitenzahl: 376
• Erscheinungstermin: 28. April 2014
• Englisch
• Abmessung: 240mm x 161mm x 25mm
• Gewicht: 739g
• ISBN-13: 9780470938430
• ISBN-10: 0470938439
• Artikelnr.: 40028967

Autorenporträt

TAPAN K. DAS is the Director of the Mass Spectrometry and Biophysics Center of Excellence in the Analytical Development and Testing group at Bristol-Myers Squibb. He is responsible for biophysical and analytical development for biotherapeutics structure-function characterization, analytical comparability, protein particulate analysis, and support for commercial biotherapeutics products. Dr. Das is also the Chair of the Biotechnology Section of Ameri an Association of Pharmaceutical Scientists.

Inhaltsangabe

PREFACE VII ABOUT THE EDITOR IX CONTRIBUTORS XI SECTION 1 EARLY DISCOVERY STAGES AND BIOTHERAPEUTIC CANDIDATE SELECTION 1 BIOPHYSICAL METHODS APPLIED IN EARLY DISCOVERY OF A BIOTHERAPEUTIC: CASE STUDY OF AN EGFR-IGF1R BISPECIFIC ADNECTIN 3 Michael L. Doyle
James W. Bryson
Virginie Lafont
Zheng Lin
Paul E. Morin
Lumelle A. Schneeweis
Aaron P. Yamniuk
and Joseph Yanchunas Jr. 2 X-RAY CRYSTALLOGRAPHY FOR BIOTHERAPEUTICS 25 Glen Spraggon 3 SOLUBILITY AND EARLY ASSESSMENT OF STABILITY FOR PROTEIN THERAPEUTICS 65 Sheng-Jiun Wu
Gary L. Gilliland
and Yiqing Feng SECTION 2 FIRST-IN-HUMAN AND UP TO PROOFOF-CONCEPT CLINICAL TRIALS 4 BIOPHYSICAL AND STRUCTURAL CHARACTERIZATION NEEDED PRIOR TO PROOF OF CONCEPT 95 Angela W. Blake-Haskins
Yen-Huei Lin
Zhuchun Wu
Melissa D. Perkins
and Thomas M. Spitznagel 5 NUCLEATION
AGGREGATION
AND CONFORMATIONAL DISTORTION 125 Christopher J. Roberts 6 UTILIZATION OF CHEMICAL LABELING AND MASS SPECTROMETRY FOR THE BIOPHYSICAL CHARACTERIZATION OF BIOPHARMACEUTICALS 151 Justin B. Sperry and Lisa M. Jones 7 APPLICATION OF BIOPHYSICAL AND HIGH-THROUGHPUT METHODS IN THE PREFORMULATION OF THERAPEUTIC PROTEINS--FACTS AND FICTIONS 173 Ahmad M. Abdul-Fattah and Hanns-Christian Mahler 8 BIOANALYTICAL METHODS AND IMMUNOGENICITY ASSAYS 207 Bonita Rup
Corinna Krinos-Fiorotti
Boris Gorovits
and Hendrik Neubert 9 STRUCTURES AND DYNAMICS OF PROTEINS PROBED BY UV RESONANCE RAMAN SPECTROSCOPY 243 Brian S. Leigh
Diana E. Schlamadinger
and Judy E. Kim 10 FREEZING- AND DRYING-INDUCED MICRO- AND NANO-HETEROGENEITY IN BIOLOGICAL SOLUTIONS 269 Alptekin Aksan
Vishard Ragoonanan
and Carol Hirschmugl SECTION 3 PHASE III AND COMMERCIAL DEVELOPMENT 11 LATE-STAGE PRODUCT CHARACTERIZATION: APPLICATIONS IN FORMULATION
PROCESS
AND MANUFACTURING DEVELOPMENT 287 Christine P. Chan and Li Shi 12 BIOPHYSICAL ANALYSES SUITABLE FOR CHEMISTRY
MANUFACTURING
AND CONTROL SECTIONS OF THE BIOLOGIC LICENSE APPLICATION (BLA) 317 Zahra Shahrokh
Nazila Salamat-Miller
and John J. Thomas INDEX 355