Das Biophysical Methods for Biotherapeutics

Discovery and Development Applications
1. Auflage 2014
ISBN: 978-1-118-35468-1
Verlag: John Wiley & Sons
Format: EPUB
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 376 Seiten, E-Book

With a focus on practical applications of biophysicaltechniques, this book links fundamental biophysics to the processof biopharmaceutical development.
* Helps formulation and analytical scientists inpharma and biotech better understand and use biophysicalmethods
* Chapters organized according to the sequential natureof the drug development process
* Helps formulation, analytical, and bioanalyticalscientists in pharma and biotech better understand and usestrengthsand limitations of biophysical methods
* Explains how to use biophysical methods, theinformation obtained, and what needs to be presented in aregulatory filing, assess impact on quality andimmunogenicity
* With a focus on practical applications of biophysicaltechniques, this book links fundamental biophysics to the processof biopharmaceutical development.

Autoren/Hrsg.

Das, Tapan K.

Inhaltsverzeichnis

PREFACE VII
ABOUT THE EDITOR IX
CONTRIBUTORS XI
SECTION 1 EARLY DISCOVERY STAGES AND BIOTHERAPEUTIC CANDIDATESELECTION
1 BIOPHYSICAL METHODS APPLIED IN EARLY DISCOVERY OF ABIOTHERAPEUTIC: CASE STUDY OF AN EGFR-IGF1R BISPECIFIC ADNECTIN3
Michael L. Doyle, James W. Bryson, Virginie Lafont, Zheng Lin,Paul E. Morin, Lumelle A. Schneeweis, Aaron P. Yamniuk, and JosephYanchunas Jr.
2 X-RAY CRYSTALLOGRAPHY FOR BIOTHERAPEUTICS 25
Glen Spraggon
3 SOLUBILITY AND EARLY ASSESSMENT OF STABILITY FOR PROTEINTHERAPEUTICS 65
Sheng-Jiun Wu, Gary L. Gilliland, and Yiqing Feng
SECTION 2 FIRST-IN-HUMAN AND UP TO PROOFOF-CONCEPT CLINICALTRIALS
4 BIOPHYSICAL AND STRUCTURAL CHARACTERIZATION NEEDED PRIOR TOPROOF OF CONCEPT 95
Angela W. Blake-Haskins, Yen-Huei Lin, Zhuchun Wu, Melissa D.Perkins,and Thomas M. Spitznagel
5 NUCLEATION, AGGREGATION, AND CONFORMATIONALDISTORTION 125
Christopher J. Roberts
6 UTILIZATION OF CHEMICAL LABELING AND MASS SPECTROMETRY FORTHE BIOPHYSICAL CHARACTERIZATION OF BIOPHARMACEUTICALS151
Justin B. Sperry and Lisa M. Jones
7 APPLICATION OF BIOPHYSICAL AND HIGH-THROUGHPUT METHODS INTHE PREFORMULATION OF THERAPEUTIC PROTEINS--FACTS AND FICTIONS173
Ahmad M. Abdul-Fattah and Hanns-Christian Mahler
8 BIOANALYTICAL METHODS AND IMMUNOGENICITY ASSAYS207
Bonita Rup, Corinna Krinos-Fiorotti, Boris Gorovits, and HendrikNeubert
9 STRUCTURES AND DYNAMICS OF PROTEINS PROBED BY UV RESONANCERAMAN SPECTROSCOPY 243
Brian S. Leigh, Diana E. Schlamadinger, and Judy E. Kim
10 FREEZING- AND DRYING-INDUCED MICRO- AND NANO-HETEROGENEITYIN BIOLOGICAL SOLUTIONS 269
Alptekin Aksan, Vishard Ragoonanan, and Carol Hirschmugl
SECTION 3 PHASE III AND COMMERCIAL DEVELOPMENT
11 LATE-STAGE PRODUCT CHARACTERIZATION: APPLICATIONS INFORMULATION, PROCESS, AND MANUFACTURING DEVELOPMENT 287
Christine P. Chan and Li Shi
12 BIOPHYSICAL ANALYSES SUITABLE FOR CHEMISTRY,MANUFACTURING, AND CONTROL SECTIONS OF THE BIOLOGIC LICENSEAPPLICATION (BLA) 317
Zahra Shahrokh, Nazila Salamat-Miller, and John J.Thomas
INDEX 355

Über Autor(innen)

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 American Association of Pharmaceutical Scientists.