{"product_id":"biophysical-methods-for-biotherapeutics-isbn-9780470938430","title":"Biophysical Methods for Biotherapeutics","description":"\u003cp\u003eWith a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development.\u003c\/p\u003e \u003cp\u003e• Helps formulation and analytical scientists in pharma and biotech better understand and use biophysical methods\u003cbr\u003e • Chapters organized according to the sequential nature of the drug development process\u003cbr\u003e • Helps formulation, analytical, and bioanalytical scientists in pharma and biotech better understand and usestrengths and limitations of biophysical methods\u003cbr\u003e • 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\u003cbr\u003e • With a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development.\u003c\/p\u003e \u003cp\u003ePreface vii\u003c\/p\u003e \u003cp\u003eAbout the Editor ix\u003c\/p\u003e \u003cp\u003eContributors xi\u003c\/p\u003e \u003cp\u003e\u003cb\u003eSection 1 Early Discovery Stages and Biotherapeutic Candidate Selection\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e1 Biophysical Methods Applied in Early Discovery of a Biotherapeutic: Case Study of an EGFR-IGF1R Bispecific Adnectin 3\u003cbr\u003e\u003ci\u003eMichael L. Doyle, James W. Bryson, Virginie Lafont, Zheng Lin, Paul E. Morin, Lumelle A. Schneeweis, Aaron P. Yamniuk, and Joseph Yanchunas Jr.\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e2 X-Ray Crystallography for Biotherapeutics 25\u003cbr\u003e\u003ci\u003eGlen Spraggon\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e3 Solubility and Early Assessment of Stability for Protein Therapeutics 65\u003cbr\u003e\u003ci\u003eSheng-Jiun Wu, Gary L. Gilliland, and Yiqing Feng\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003eSection 2 First-in-Human and up to Proof-of-Concept Clinical Trials\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e4 Biophysical and Structural Characterization Needed Prior to Proof of Concept 95\u003cbr\u003e\u003ci\u003eAngela W. Blake-Haskins, Yen-Huei Lin, Zhuchun Wu, Melissa D. Perkins, and Thomas M. Spitznagel\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e5 Nucleation, Aggregation, and Conformational Distortion 125\u003cbr\u003e\u003ci\u003eChristopher J. Roberts\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e6 Utilization of Chemical Labeling and Mass Spectrometry for the Biophysical Characterization of Biopharmaceuticals 151\u003cbr\u003e\u003ci\u003eJustin B. Sperry and Lisa M. Jones\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e7 Application of Biophysical and High-Throughput Methods in the Preformulation of Therapeutic Proteins—Facts and Fictions 173\u003cbr\u003e\u003ci\u003eAhmad M. Abdul-Fattah and Hanns-Christian Mahler\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e8 Bioanalytical Methods and Immunogenicity Assays 207\u003cbr\u003e\u003ci\u003eBonita Rup, Corinna Krinos-Fiorotti, Boris Gorovits, and Hendrik Neubert\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e9 Structures and Dynamics of Proteins Probed by UV Resonance Raman Spectroscopy 243\u003cbr\u003e\u003ci\u003eBrian S. Leigh, Diana E. Schlamadinger, and Judy E. Kim\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e10 Freezing- and Drying-Induced Micro- and Nano-Heterogeneity in Biological Solutions 269\u003cbr\u003e\u003ci\u003eAlptekin Aksan, Vishard Ragoonanan, and Carol Hirschmugl\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003eSection 3 Phase III and Commercial Development\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e11 Late-Stage Product Characterization: Applications in Formulation, Process, and Manufacturing Development 287\u003cbr\u003e\u003ci\u003eChristine P. Chan and Li Shi\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e12 Biophysical Analyses Suitable for Chemistry, Manufacturing, and Control Sections of the Biologic License Application (BLA) 317\u003cbr\u003e\u003ci\u003eZahra Shahrokh, Nazila Salamat-Miller, and John J. Thomas\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eIndex 355\u003c\/p\u003e  \u003cp\u003e\u003cb\u003eTAPAN K. DAS\u003c\/b\u003e 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.   \u003c\/p\u003e\u003cp\u003e\u003cb\u003eA guide to link and apply biophysics for developing biopharmaceuticals\u003c\/b\u003e \u003c\/p\u003e\u003cp\u003eThis book focuses on the application of biophysical techniques and methods in the development of biotherapeutics. Four areas, all focusing on biotherapeutics development, are emphasized— (1) novel applications and new methods of traditional biophysical techniques, (2) novel and emerging technologies and their applications, (3) biophysical applications relevant to stage-wise development of a clinical biotherapeutic candidate, and (4) thermodynamic, conformational, and stabilization concepts aided by biophysical research. \u003c\/p\u003e\u003cp\u003eThe chapters are laid out in a theme based on clinical phases of development. This allows for a comprehensive view of: \u003c\/p\u003e\u003cul\u003e \u003cli\u003eWhich biophysical studies are needed for which stage and for what purpose,\u003c\/li\u003e \u003cli\u003eHow and when to apply the techniques,\u003c\/li\u003e \u003cli\u003eWhat types of characterization regulatory agencies expect, and\u003c\/li\u003e \u003cli\u003eThe limitations of each technique and type of application.\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eOverall, this book helps formulation, analytical, and bioanalytical scientists in pharma and biotech industries better understand and use biophysical methods and assess impact on quality and immunogenicity. It also provides information to help organizations develop short- and long-term strategies for resource investment in biophysical research.\u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47988840431845,"sku":"NP9780470938430","price":144.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9780470938430.jpg?v=1761781728","url":"https:\/\/k12savings.com\/products\/biophysical-methods-for-biotherapeutics-isbn-9780470938430","provider":"K12savings","version":"1.0","type":"link"}