Pharmaceutical Biotechnology: Fundamentals and Applications Third edition provides a well-balanced framework for understanding every major aspect of pharmaceutical biotechnology, including drug development, production, dosage forms, administration, and therapeutic developments.

New chapters cover evolving areas regarding biopharmaceuticals, including oligonucleotides, siRNA and various monoclonal antibodies, immunogenicity, gene therapy, and the regulatory issues factoring into the biopharmaceutical approval process.

Features:

• discusses general concepts in the production and clinical pharmacology of monoclonal antibodies, as well as their therapeutic application in cancer treatment, immunosuppressive therapy related to organ transplantation, and anti-inflammatory therapy
• describes regulatory requirements of biotechnology drug products to receive approval to market
• presents challenges and approaches for overcoming an undesired immune response to protein therapeutics
• addresses the discovery and clinical development of the new biotechnology-produced drugs

Contents

1. Molecular Biotechnology
2. Biophysical and Biochemical Analysis of Recombinant Protein Structure and Analysis of Proteins
3. Production and Downstream Processing of Biotech Products
4. Formulation of Biotech Products, Including Biopharmaceutical Considerations
5. Pharmacokinetics and Pharmacodynamics of Peptide and Protein Drugs
6. Immunogenicity
7. Genomics, Proteomics and Additional Biotechnology-related Techniques
8. Gene Therapy
9. Oligonucleotides and siRNA
10. Hematopoetic Growth Factors
11. Interferons and Interleukins
12. Insulins
13. Growth Hormones
14. Recombinant Thrombolytics and Coagulation Factors
15. General Considerations of Monoclonal Antibodies
16. Monoclonal Antibodies in Oncology
17. Monoclonal Antibodies in Transplantation
18. Monoclonal Antibodies in Anti-inflammatory Therapy
19. Recombinant Human Deoxyribonuclease
20. Follicle-stimulating Hormone
21. Vaccines
22. Dispensing Biotechnology Products
23. Economic Considerations in Medical Biotechnology
24. Regulatory Issues and Drug Product Approval for Biopharmaceuticals

Index

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