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  • Book
  • © 2013

Biophysics for Therapeutic Protein Development

Editors:

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

    • Yijia Jiang, Cynthia Li, John Gabrielson
    Pages 99-126
  6. Application of Biophysics in Formulation, Process, and Product Characterization: Selected Case Studies

    • Satish K. Singh, Qin Zou, Min Huang, Muralidhara Bilikallahalli
    Pages 147-172
  7. 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
  8. 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
  9. Investigation of Nonconformance During Protein Therapeutic Manufacturing

    • Zai-Qing Wen, Gianni Torraca, Guiyang Li, Xiaolin Cao, Chanel K. Yee
    Pages 245-260
  10. 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
  11. Back Matter

    Pages 283-293

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

Bibliographic Information

Buy it now

Buying options

eBook USD 129.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book USD 169.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book USD 169.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Other ways to access