Pharmaceutical Biotechnology

Preface vii
Abbreviations ix
Contributors xix
1. Molecular Biotechnology: From DNA Sequence
to Therapeutic Protein 1
Ronald S. Oosting
2. Biophysical and Biochemical Analysis of Recombinant Proteins 19
Tsutomu Arakawa and John S. Philo
3. Production and Purifi cation of Recombinant Proteins 47
Farida Kadir, Paul Ives, Alfred Luitjens, and Emile van Corven
4. Formulation of Biotech Products, Including Biopharmaceutical
Considerations 69
Daan J.A. Crommelin
5. Pharmacokinetics and Pharmacodynamics of Peptide and Protein
Therapeutics 101
Bernd Meibohm
6. Immunogenicity of Therapeutic Proteins 133
Huub Schellekens and Wim Jiskoot
7. Monoclonal Antibodies: From Structure to Therapeutic Application 143
John D. Davis, Rong Deng, C. Andrew Boswell, Yi Zhang, Jing Li, Paul Fielder, Amita
Joshi, and Saraswati Kenkare-Mitra
8. Genomics, Other “Omic” Technologies, Personalized Medicine,
and Additional Biotechnology-Related Techniques 179
Robert D. Sindelar
9. Dispensing Biotechnology Products: Handling, Professional Education,
and Product Information 223
Peggy Piascik and Val Adams
10. Economic Considerations in Medical Biotechnology 237
Eugene M. Kolassa and Tushar B. Padwal
11. Regulatory Framework for Biosimilars 247
Vinod P. Shah and Daan J.A. Crommelin
12. Insulin 255
John M. Beals, Michael R. DeFelippis, Paul M. Kovach, and Jeffrey A. Jackson
13. Follicle-Stimulating Hormone 277
Tom Sam, Renato de Leeuw, Gijs Verheijden, and Anneke Koole
14. Human Growth Hormone 285
Le N. Dao, Barbara Lippe, and Michael Laird
Contents
15. Recombinant Coagulation Factors and Thrombolytic Agents 299
Nishit B. Modi
16. Recombinant Human Deoxyribonuclease I 321
Robert A. Lazarus and Jeffrey S. Wagener
17. Monoclonal Antibodies in Cancer 337
Amy Grimsley, Katherine Shah, and Trevor McKibbin
18. Hematopoietic Growth Factors: Focus
on Erythropoiesis-Stimulating Agents 361
Juan Jose Pérez-Ruixo and Andrew T. Chow
19. Monoclonal Antibodies in Solid Organ Transplantation 375
Nicole A. Pilch, Holly B. Meadows, and Rita R. Alloway
20. Monoclonal Antibodies and Antibody-Based Biotherapeutics
in Infl ammatory Diseases 393
Honghui Zhou, Zhenhua Xu, Mary Ann Mascelli, and Hugh M. Davis
21. Interferons and Interleukins 413
Jean-Charles Ryff and Sidney Pestka
22. Vaccines 439
Wim Jiskoot, Gideon F.A. Kersten, and Enrico Mastrobattista
23. Oligonucleotides 459
Raymond M. Schiffelers and Enrico Mastrobattista
24. Gene Therapy 477
Hao Wu and Ram I. Mahato
25. Stem Cell Technology 509
Colin W. Pouton
Index 525