Biotechnology & biopharmaceuticals : transforming proteins and genes into drugs

Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs defines biotechnology from the perspective of pharmaceuticals. The first section focuses on the process of transforming a biologic macromolecule into a therapeutic agent, while the second section provides a brief overview of each class of macromolecule with respect to physiological role and clinical application. Additional detail is also provided in the second section for each FDA approved, recombinantly derived biopharmaceutical for each category of macromolecule. The final section looks to the future and the new advances that will enhance our ability to develop new macromolecules into effective biopharmaceuticals. This last section discusses various drug delivery strategies while also describing gene and cell therapy strategies.

Foreword (Ronald T. Borchardt).Preface. Part 1: TRANSFORMING PROTEINS AND GENES INTO THERAPEUTICS . Introduction to Biopharmaceuticals. Development of Drugs that are Proteins and Genes Versus Small Molecules. Biotechnology Industry Perspective on Drug Development. Biopharmaceutical Technologies and Processes in Drug Development. Pharmacology, Toxicology, Therapeutic Dosage Formulations and Clinical Responses. Part 2: THERAPEUTICS BASED ON BIOTECHNOLOGY . Hematopoietic Growth Factors and Coagulation Factors. Interferon and Cytokines for Anti-Infective and Cancer Therapy. Hormones.Enzymes. Antibodies and Derivatives. Vaccines.Other Products. Part 3: FUTURE DIRECTIONS . Advanced Drug Delivery. Individualization of Drug Regimens: Integration of Pharmacokinetic and Pharmacognetic Principles in Drug Therapy. Gene and Cell Therapy. Integration of Discovery and Development: The Role Genomics and Proteomics. Appendix I. Pharmacokinetics and Disposition Data. Appendix II. Molecular Characteristic and Therapeutic Use. Appendix III. Nomenclature of Biotechnology Products. Appendix IV. Synonym of Trade, Common, and Scientific Names of Biotechnology Products. Appendix V. Other Information.