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© 2019

Pharmaceutical Biotechnology

Fundamentals and Applications

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

Table of contents

  1. Front Matter
    Pages i-xxiii
    PDF
  2. Molecular Biotechnology: From DNA Sequence to Therapeutic Protein
    Ronald S. Oosting
    Pages 1-18
  3. Biophysical and Biochemical Characteristics of Therapeutic Proteins
    Wim Jiskoot, Daan J. A. Crommelin
    Pages 19-32
  4. Protein Stability and Characterization
    Atanas Koulov
    Pages 33-56
  5. Production and Purification of Recombinant Proteins
    Alfred Luitjens, Emile van Corven
    Pages 57-82
  6. Formulation of Biologics Including Biopharmaceutical Considerations
    Daan J. A. Crommelin, Andrea Hawe, Wim Jiskoot
    Pages 83-103
  7. Pharmacokinetics and Pharmacodynamics of Therapeutic Peptides and Proteins
    Bernd Meibohm
    Pages 105-137
  8. Immunogenicity of Therapeutic Proteins
    Wim Jiskoot, Theo Rispens, Grzegorz Kijanka
    Pages 139-150
  9. Monoclonal Antibodies: From Structure to Therapeutic Application
    Rong Deng, C. Andrew Boswell, Wendy S. Putnam, Meina T. Tang, Amit Garg, Chunze Li et al.
    Pages 151-190
  10. Genomics, Other “OMIC” Technologies, Precision Medicine, and Additional Biotechnology-Related Techniques
    Robert D. Sindelar
    Pages 191-237
  11. Dispensing Biotechnology Products: Handling, Professional Education, and Product Information
    Robert D. Sindelar
    Pages 239-251
  12. Economic Considerations in Medical Biotechnology
    Amit S. Patel, Kartick P. Shirur
    Pages 253-263
  13. Regulatory Framework for Biosimilars
    Vinod P. Shah, Daan J. A. Crommelin
    Pages 265-274
  14. An Evidence-Based Practice Approach to Evaluating Biotechnologically Derived Medications
    James P. McCormack
    Pages 275-280
  15. Vaccines
    Wim Jiskoot, Gideon F. A. Kersten, Enrico Mastrobattista, Bram Slütter
    Pages 281-304
  16. Oligonucleotides
    Raymond M. Schiffelers, Erik Oude Blenke, Enrico Mastrobattista
    Pages 305-322
  17. Gene Therapy
    Hao Wu, Amit Kumar Chaudhary, Ram I. Mahato
    Pages 323-355
  18. Advanced Therapies: Clinical, Non-clinical and Quality Considerations
    Karin H. Hoogendoorn
    Pages 357-402
  19. Insulin
    John M. Beals, Michael R. DeFelippis, Chad D. Paavola, David P. Allen, Ashish Garg, D. Bruce Baldwin
    Pages 403-427
  20. Follicle-Stimulating Hormone
    Tom Sam, Renato de Leeuw
    Pages 429-435

About this book

Introduction

This introductory text explains both the basic science and the applications of biotechnology derived pharmaceuticals, with special emphasis on their clinical use. It serves as a complete one-stop source for undergraduate/graduate pharmacists, pharmaceutical science students,
and for those who did not receive formal training in this field. Pharmaceutical Biotechnology: Fundamentals and Applications, Fifth Edition completely updates the previous edition, and includes additional coverage on newer approaches such as oligonucleotides, mi/siRNA, gene therapy and advanced therapeutics.

Daan J.A. Crommelin is Professor Emeritus Department of Pharmaceutical Sciences, Utrecht Institute for Pharmaceutical Sciences at Utrecht University, Utrecht, The Netherlands and Adjunct Professor in the Department of Pharmaceutics and Pharmaceutical Chemistry at the University of Utah, Salt Lake City, UT, USA

Robert D. Sindelar is Professor and former Dean Faculty of Pharmaceutical Sciences and The Centre for Health Evaluation & Outcomes Sciences (CHEOS), The University of British Columbia (UBC), Vancouver, BC, Canada and President of the Global Drug Commercialization Centre (GDCC)-China and Vice-President GDCC-worldwide, Chengdu, China

Bernd Meibohm is Professor of Pharmaceutical Sciences and Associate Dean for Research and Graduate Programs at the University of Tennessee Health Science Center, College of Pharmacy, Memphis, TN, USA

Keywords

Stem cell Enzyme Replacement Therapy recombinant proteins molecular biotechnology pharmacokinetics and Pharmacodymanics proteins and peptides immunogenecity monoclonal antibodies genomics personalized medicine biosimilars vaccines gene therapy FSH

Editors and affiliations

  • Daan J. A. Crommelin
    • 1
  • Robert D. Sindelar
    • 2
  • Bernd Meibohm
    • 3
  1. 1.Utrecht UniversityUtrechtThe Netherlands
  2. 2.Faculty of Pharmaceutical Sciences and The Centre for Health Evaluation & Outcomes Sciences (CHEOS)The University of British Columbia (UBC)VancouverCanada
  3. 3.College of PharmacyUniversity of Tennessee, Health Science CenterMemphisUSA

About the editors

Daan J.A. Crommelin is Professor Emeritus Department of Pharmaceutical Sciences, Utrecht Institute for Pharmaceutical Sciences at Utrecht University, Utrecht, The Netherlands and Adjunct Professor in the Department of Pharmaceutics and Pharmaceutical Chemistry at the University of Utah, Salt Lake City, UT, USA


Robert D. Sindelar is Professor and former Dean Faculty of Pharmaceutical Sciences and The Centre for Health Evaluation & Outcomes Sciences (CHEOS), The University of British Columbia (UBC), Vancouver, BC, Canada and President of the Global Drug Commercialization Centre (GDCC)-China and Vice-President GDCC-worldwide, Chengdu, China


Bernd Meibohm is Professor of Pharmaceutical Sciences and Associate Dean for Research and Graduate Programs at the University of Tennessee Health Science Center, College of Pharmacy, Memphis, TN, USA


Bibliographic information