With a focus on practical applications of biophysical techniques, Biophysical Methods for Biotherapeutics helps formulation and analytical scientists in pharma and biotech better understand and use biophysical methods. Author Tapan K. Das links fundamental biophysics to the process of biopharmaceutical development using a chapter organization according to the steps of the drug development process. The text provides information to help organizations develop short– and long–term strategies for resource investment in biophysical research. INDICE: Preface About the Editor Contributors Section 1 Chapter 1 Biophysical Methods Applied in Early Discovery of a Biotherapeutic: Case Study of an EGFR–IGF1R Bispecific Adnectin Michael L. Doyle, James W. Bryson, Virginie Lafont, Zheng Lin, Paul E. Morin, Lumelle A. Schneeweis, Aaron P. Yamniuk, and Joseph Yanchunas Jr. Chapter 2 X–ray Crystallography for Biotherapeutics Glen Spraggon Chapter 3 Solubility and Early Assessment of Stability For Protein Therapeutics Sheng–Jiun Wu, Gary L. Gilliland and Yiqing Feng Section 2 Chapter 4 Biophysical and Structural Characterization Needed Prior to Proof of Concept Angela W. Blake–Haskins, Yen–Huei Lin, Zhuchun Wu, Melissa D. Perkins, Thomas M. Spitznagel Chapter 5 Nucleation, Aggregation, and Conformational Distortion Christopher J. Roberts Chapter 6 Utilization of Chemical Labeling and Mass Spectrometry for the Biophysical Characterization of Biopharmaceuticals Justin B. Sperry and Lisa M. Jones Chapter 7 Application of Biophysical and High Throughput Methods in the Preformulation of Therapeutic Proteins – Facts and Fictions Ahmad M. Abdul–Fattah and Hanns–Christian Mahler Chapter 8 Bioanalytical Methods and Immunogenicity Assays Bonita Rup, Corinna Krinos–Fiorotti, Boris Gorovits, Hendrik Neubert Chapter 9 Structures and Dynamics of Proteins Probed by UV Resonance Raman Spectroscopy Brian S. Leigh, Diana E. Schlamadinger, and Judy E. Kim Chapter 10 Freezing and drying–induced micro–/nanoheterogeneity in biological solutions Alptekin Aksan, Vishard Ragoonanan, and Carol Hirschmugl Section 3 Chapter 11 Late stage product characterization: applications in formulation, process and manufacturing development Christine P. Chan and Li Shi Chapter 12 Biophysical Analyses Suitable for Chemistry, Manufacturing and Control Sections of the Biological License Application (BLA) Zahra Shahrokh, Nazila Salamat–Miller, John J. Thomas
- ISBN: 978-0-470-93843-0
- Editorial: Wiley–Blackwell
- Encuadernacion: Cartoné
- Páginas: 386
- Fecha Publicación: 16/05/2014
- Nº Volúmenes: 1
- Idioma: Inglés