Featuring completely revised text that reflects to emergent trends and cutting-edge advances in pharmaceutical biotechnology, this 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.
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