Pharmaceutical Biotechnology

Fundamentals and Applications

  • Daan J. A. Crommelin
  • Robert D. Sindelar
  • Bernd Meibohm

Table of contents

  1. Front Matter
    Pages i-xxi
  2. Tsutomu Arakawa, John S. Philo
    Pages 19-45
  3. Farida Kadir, Paul Ives, Alfred Luitjens, Emile van Corven
    Pages 47-67
  4. Huub Schellekens, Wim Jiskoot
    Pages 133-141
  5. John D. Davis, Rong Deng, C. Andrew Boswell, Yi Zhang, Jing Li, Paul Fielder et al.
    Pages 143-178
  6. Eugene M. Kolassa, Tushar B. Padwal
    Pages 237-245
  7. Vinod P. Shah, Daan J. A. Crommelin
    Pages 247-254
  8. John M. Beals, Michael R. DeFelippis, Paul M. Kovach, Jeffrey A. Jackson
    Pages 255-275
  9. Tom Sam, Renato de Leeuw, Gijs Verheijden, Anneke Koole
    Pages 277-283
  10. Le N. Dao, Barbara Lippe, Michael Laird
    Pages 285-298
  11. Robert A. Lazarus, Jeffrey S. Wagener
    Pages 321-336
  12. Amy Grimsley, Katherine S. Shah, Trevor McKibbin
    Pages 337-359
  13. Juan Jose Pérez-Ruixo, Andrew T. Chow
    Pages 361-374
  14. Nicole A. Pilch, Holly B. Meadows, Rita R. Alloway
    Pages 375-391
  15. Honghui Zhou, Zhenhua Xu, Mary Ann Mascelli, Hugh M. Davis
    Pages 393-412
  16. Jean-Charles Ryff, Sidney Pestka
    Pages 413-437
  17. Wim Jiskoot, Gideon F. A. Kersten, Enrico Mastrobattista
    Pages 439-457
  18. Raymond M. Schiffelers, Enrico Mastrobattista
    Pages 459-475
  19. Hao Wu, Ram I. Mahato
    Pages 477-507
  20. Colin W. Pouton
    Pages 509-524
  21. Back Matter
    Pages 525-544

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

  • Daan J. A. Crommelin
    • 1
  • Robert D. Sindelar
    • 2
  • Bernd Meibohm
    • 3
  1. 1.Department of Pharmaceutical SciencesUtrecht UniversityUtrechtThe Netherlands
  2. 2.Department of Pharmaceutical Sciences and Department of MedicineThe University of British ColumbiaVancouverCanada
  3. 3.Department of Pharmaceutical SciencesUniversity of Tennessee Health Science Center, College of PharmacyMemphisUSA

Bibliographic information