Pharmaceutical Biotechnology: Fundamentals and Applications

Summary

The Third Edition of this important reference is completely revised to reflect significant trends and cutting-edge advances in pharmaceutical biotechnology, including specific therapeutic agents and their applications.

it 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 oligonucleotides and sirnA, regulatory issues and drug product approval for biopharmaceuticals, immunogenicity, gene therapy, and various monoclonal antibodies grouped by therapeutic area.

Contents

• Molecular Biotechnology
• Biophysical and Biochemical Analysis of Recombinant Protein Structure and Analysis of Proteins
• Production and Downstream Processing of Biotech Products
• Formulation of Biotech Products, Including Biopharmaceutical Considerations
• Pharmacokinetics and Pharmacodynamics of Peptide and Protein Drugs
• Immunogenicity
• Genomics, Proteomics and Additional Biotechnology-Related Techniques
• Gene Therapy
• Oligonucleotides and Sirna
• Hematopoetic Growth Factors
• Interferons and Interleukins
• Insulins
• Growth Hormones
• Recombinant Thrombolytics and Coagulation Factors
• General Considerations of Monoclonal Antibodies
• Monoclonal Antibodies in Oncology
• Monoclonal Antibodies in Transplantation
• Monoclonal Antibodies in Anti-Inflammatory Therapy
• Recombinant Human Deoxyribonuclease
• Follicle-Stimulating Hormone
• Vaccines
• Dispensing Biotechnology Products
• Economic Considerations in Medical Biotechnology
• Regulatory Issues and Drug Product Approval for Biopharmaceuticals