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  • © 2013

Pharmaceutical Biotechnology

Fundamentals and Applications

  • Explains the basic science and the applications of biotechnology-derived pharmaceuticals

  • Serves as a complete one-stop source for undergraduate pharmacists, pharmaceutical science students, and for those in the pharmaceutical industry

  • Includes additional coverage on the newer approaches

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eBook USD 84.99
Price excludes VAT (USA)
  • ISBN: 978-1-4614-6486-0
  • Instant PDF download
  • Readable on all devices
  • Own it forever
  • Exclusive offer for individuals only
  • Tax calculation will be finalised during checkout
Softcover Book USD 109.99
Price excludes VAT (USA)
Hardcover Book USD 139.99
Price excludes VAT (USA)

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Table of contents (25 chapters)

  1. Front Matter

    Pages i-xxi
  2. Biophysical and Biochemical Analysis of Recombinant Proteins

    • Tsutomu Arakawa, John S. Philo
    Pages 19-45
  3. Production and Purification of Recombinant Proteins

    • Farida Kadir, Paul Ives, Alfred Luitjens, Emile van Corven
    Pages 47-67
  4. Immunogenicity of Therapeutic Proteins

    • Huub Schellekens, Wim Jiskoot
    Pages 133-141
  5. Monoclonal Antibodies: From Structure to Therapeutic Application

    • John D. Davis, Rong Deng, C. Andrew Boswell, Yi Zhang, Jing Li, Paul Fielder et al.
    Pages 143-178
  6. Economic Considerations in Medical Biotechnology

    • Eugene M. Kolassa, Tushar B. Padwal
    Pages 237-245
  7. Regulatory Framework for Biosimilars

    • Vinod P. Shah, Daan J. A. Crommelin
    Pages 247-254
  8. Insulin

    • John M. Beals, Michael R. DeFelippis, Paul M. Kovach, Jeffrey A. Jackson
    Pages 255-275
  9. Follicle-Stimulating Hormone

    • Tom Sam, Renato de Leeuw, Gijs Verheijden, Anneke Koole
    Pages 277-283
  10. Human Growth Hormone

    • Le N. Dao, Barbara Lippe, Michael Laird
    Pages 285-298
  11. Recombinant Human Deoxyribonuclease I

    • Robert A. Lazarus, Jeffrey S. Wagener
    Pages 321-336
  12. Monoclonal Antibodies in Cancer

    • Amy Grimsley, Katherine S. Shah, Trevor McKibbin
    Pages 337-359
  13. Hematopoietic Growth Factors: Focus on Erythropoiesis-Stimulating Agents

    • Juan Jose Pérez-Ruixo, Andrew T. Chow
    Pages 361-374
  14. Monoclonal Antibodies in Solid Organ Transplantation

    • Nicole A. Pilch, Holly B. Meadows, Rita R. Alloway
    Pages 375-391

About this book

Setting the standard for modern biopharmaceutical education, the new Fourth Edition is a completely revised text to reflect the rapid growth in the importance of biopharmaceuticals and the techniques of biotechnologies to modern medicine and the life sciences.  The editors have provided a well-balanced framework for introductory as well as more detailed education in various aspects of pharmaceutical biotechnology and the production, biopharmaceutics, and clinical pharmacology of biotechnology-produced drugs.  The new edition improves upon the strong chapters of previous editions, adding emergent trends and cutting-edge advances as well as new graphic illustrations and new authors.  The textbook includes key concepts at the foundation of the technology relevant for protein therapeutics including molecular biology, production and analysis procedures, formulation development, pharmacokinetics and pharmacodynamics, and immunogenicity, as well as chapters dealing with regulatory, economic, and pharmacy practice considerations.


The Fourth Edition brings an exciting and fundamental reorganization of the text, now structured into two sections: 1) an initial basic science and general features section; and 2) a section profiling the various therapeutic classes of biologics, including gene therapy.  Additionally, reorganization of the chapters examining the properties and applications of monoclonal antibodies, and oligonucleotides and siRNA has enhanced these important concepts in the text.  A completely new chapter has been added on cell-based technologies.


The Fourth Edition continues the popular self-assessment questions after each chapter to reinforce understanding of practical pharmaceutical applications, making this an indispensable text for self-study, the biopharmaceutical classroom, as well as for professional reference in practice or industry. 


  • Formulation development
  • Immunogenicity
  • Molecular biology
  • Nucleotide-based therapeutics
  • Pharmacokinetics and pharmacodynamics
  • Protein therapeutics

Editors and Affiliations

  • Department of Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands

    Daan J. A. Crommelin

  • Department of Pharmaceutical Sciences and Department of Medicine, The University of British Columbia, Vancouver, Canada

    Robert D. Sindelar

  • Department of Pharmaceutical Sciences, University of Tennessee Health Science Center, College of Pharmacy, Memphis, USA

    Bernd Meibohm

About the editors

DAAN J.A. CROMMELIN is Professor at the Department of Pharmaceutics at Utrecht University. Until December 2011 he was scientific director of the Dutch Top Institute Pharma in Leiden. He is adjunct professor at the Department of Pharmaceutics and Pharmaceutical Chemistry at the University of Utah. Dr. Crommelin is co-founder of OctoPlus, a Leiden based company specialized in the development of pharmaceutical product formulations and advanced drug delivery systems. He published over 335 articles and has held leadership positions at the International Pharmaceutical Federation (FIP) and the European Federation for Pharmaceutical Sciences (EUFEPS).

ROBERT D. SINDELAR is currently President, The Providence Health Care Research Institute, Vice President Research and Academic, Providence Health Care (part of the British Columbia public health care system), Professor Faculty of Pharmaceutical Sciences and Associate Dean Research Faculty of Medicine The University of British Columbia (UBC).  He served for 11 years as Dean and Professor, The UBC Faculty of Pharmaceutical Sciences following 19 years at the University of Mississippi where he held the positions of Professor and Chair of Medicinal Chemistry, School of Pharmacy and served as Interim Dean.  Dr. Sindelar’s expertise lies in medicinal chemistry, computer-aided drug discovery and design, pharmaceutical biotechnology, and creating opportunities to integrate innovation into the health care system. 

BERND MEIBOHM is Professor of Pharmaceutical Sciences and Associate Dean for Research and Graduate Programs at the University of Tennessee College of Pharmacy in Memphis. His area of expertise lies in clinical pharmacology and pharmacokinetic/pharmacodynamics correlations. Dr. Meibohm obtained his doctoral degree in Pharmaceutics from the Technical University Carolo-Wilhelmina, Braunschweig, Germany and received postdoctoral training at the University of Florida, Gainesville. Dr. Meibohm is a fellow of the American Association of Pharmaceutical Scientists and the American College of Clinical Pharmacology, and has published three textbooks, more than 90 peer-reviewed research articles and book chapters, 130 abstracts, and over 100 invited scientific presentations to national and international audiences.

Bibliographic Information

  • Book Title: Pharmaceutical Biotechnology

  • Book Subtitle: Fundamentals and Applications

  • Editors: Daan J. A. Crommelin, Robert D. Sindelar, Bernd Meibohm

  • DOI:

  • Publisher: Springer New York, NY

  • eBook Packages: Biomedical and Life Sciences, Biomedical and Life Sciences (R0)

  • Copyright Information: Springer Science+Business Media, LLC, part of Springer Nature 2013

  • Hardcover ISBN: 978-1-4614-6485-3

  • Softcover ISBN: 978-1-4939-4339-5

  • eBook ISBN: 978-1-4614-6486-0

  • Edition Number: 4

  • Number of Pages: XXI, 544

  • Number of Illustrations: 18 b/w illustrations, 222 illustrations in colour

  • Topics: Pharmaceutics, Biomedical Research

Buying options

eBook USD 84.99
Price excludes VAT (USA)
  • ISBN: 978-1-4614-6486-0
  • Instant PDF download
  • Readable on all devices
  • Own it forever
  • Exclusive offer for individuals only
  • Tax calculation will be finalised during checkout
Softcover Book USD 109.99
Price excludes VAT (USA)
Hardcover Book USD 139.99
Price excludes VAT (USA)