One comment often repeated to me by coworkers in the biotechnology industry deals with their frustration at not understanding how their particular roles fit into their company's overall scheme for developing, manufacturing, and marketing biomedical products. Although these workers know their fields of specialty and responsibilities very well, whether it be in product research and development, regulatory affairs, manufacturing, packaging, quality control, or marketing and sales, they for the most part lack an understanding of precisely how their own contributory pieces fit into the overall scheme of the corporate biotechnology puzzle. The Biotech Business Handbook was written to assist the biotechnologist-whether a tech nician, senior scientist, manager, marketing representative, or college student interested in entering the field-in building a practical knowledge base of the rapidly expanding and maturing biotechnology segment of the healthcare industry. Because biotechnology in the United States and abroad covers many disciplines, much of the information presented in this book deals with the biomedical diagnostic aspects of the industry. Business subjects for the most part unfamiliar to technically oriented people, such as the types of biotechnology corpo rations, their business and corporate structures, their financing, patent, and trademark mat ters, their special legal issues, and the contributions of their consultants are treated in a manner designed to make them clear and understandable.
Table of ContentsThe World Biotechnology Industry. Preparing to Enter the Biotechnology Industry. Corporate Organization. Management Considerations. Legal Issues in Biotechnology. Biotechnology Funding. Biotechnology Project Development. Biotechnology Product Development. Quality Control. Quality Assurance. Manufacturing. Regulatory Compliance. Marketing the Technology. Troubleshooting Products After Release. Safety in the Biotechnology Workplace. Support Services and Facilities. Immunodiagnostic Assays. Nucleic Acid Probe Assays. Human Genome Initiative. Bioremediation. Gene Therapy Biotechnology. The Biotechnology of Transgenics. Vaccine, Drug, Antisense, and Third-Strand Therapies. Allografts, Artificial Tissues, and Organs. Appendices. Glossary. Index.