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Biophysics for Therapeutic Protein Development

  • Book
  • © 2013

Overview

Editors:
  1. Linda O. Narhi

    1. , Research & Development, Amgen, Inc., Thousand Oaks, USA

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  • Organized to mimic biotherapeutic product lifecycle
  • Focuses on the applications of biophysics to different disciplines; in particular, focusing on protein therapeutic development
  • First fully comprehensive book to cover protein aggregation and the biophysical techniques used in the development lifecycle of biopharmaceuticals
  • Includes supplementary material: sn.pub/extras

Part of the book series: Biophysics for the Life Sciences (BIOPHYS, volume 4)

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Table of contents (11 chapters)

  1. Front Matter

    Pages i-ix
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  2. Introduction

    • Linda O. Narhi
    Pages 1-5

  3. High-Throughput Biophysical Approaches to Therapeutic Protein Development

    • Feng He, Vladimir I. Razinkov, C. Russell Middaugh, Gerald W. Becker
    Pages 7-31

  4. Techniques for Higher-Order Structure Determination

    • James Kranz, Fatma AlAzzam, Atul Saluja, Juraj Svitel, Wasfi Al-Azzam
    Pages 33-82

  5. Biophysical Techniques for Protein Size Distribution Analysis

    • Ziping Wei, Alla Polozova
    Pages 83-97

  6. Qualification of Biophysical Methods for the Analysis of Protein Therapeutics

    • Yijia Jiang, Cynthia Li, John Gabrielson
    Pages 99-126

  7. Application of Biophysics to the Early Developability Assessment of Therapeutic Candidates and Its Application to Enhance Developability Properties

    • Hasige Sathish, Nicolas Angell, David Lowe, Ambarish Shah, Steven Bishop
    Pages 127-146

  8. Application of Biophysics in Formulation, Process, and Product Characterization: Selected Case Studies

    • Satish K. Singh, Qin Zou, Min Huang, Muralidhara Bilikallahalli
    Pages 147-172

  9. Biophysical Analysis in Support of Development of Protein Pharmaceuticals

    • Sreedhara Alavattam, Barthelemy Demeule, Jun Liu, Sandeep Yadav, Mary Cromwell, Steven J. Shire
    Pages 173-204

  10. Case Studies Applying Biophysical Techniques to Better Characterize Protein Aggregates and Particulates of Varying Size

    • Tingting Wang, Sangeeta B. Joshi, Ozan S. Kumru, Srivalli Telikepalli, C. Russell Middaugh, David B. Volkin
    Pages 205-243

  11. Investigation of Nonconformance During Protein Therapeutic Manufacturing

    • Zai-Qing Wen, Gianni Torraca, Guiyang Li, Xiaolin Cao, Chanel K. Yee
    Pages 245-260

  12. Higher-Order Structure and Protein Aggregate Characterization of Protein Therapeutics: Perspectives from Good Manufacturing Practices and Regulatory Guidance

    • Evi B. Struble, John F. Cipollo, Chava Kimchi-Sarfaty, Zuben E. Sauna, Jack A. Ragheb, Ewa Marszal
    Pages 261-281

  13. Back Matter

    Pages 283-293
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Keywords

About this book

This book can be used to provide insight into this important application of biophysics for those who are planning a career in protein therapeutic development, and for those outside this area who are interested in understanding it better. The initial chapters describe the underlying theory, and strengths and weaknesses of the different techniques commonly used during therapeutic development. The majority of the chapters discuss the applications of these techniques, including case studies, across the product lifecycle from early discovery, where the focus is on identifying targets, and screening for potential drug product candidates, through expression and purification, large scale production, formulation development, lot-to-lot comparability studies, and commercial support including investigations.

Editors and Affiliations

  • , Research & Development, Amgen, Inc., Thousand Oaks, USA

    Linda O. Narhi

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