Managing Biotechnology in Drug Development

Improve your understanding of biotechnology's impact on drug development, production, and regulation with Managing Biotechnology in Drug Development. This informative book unravels the complex workings of the U.S. Food and Drug Administration's regulatory processes for durgs and biological products, including vaccines and recombinant DNA-derived products. It initially reviews the important role of biotechnology in medicine and the pharmeceutical industry. It then discusses the development of drugs and biologics from a regulatory perspective, spotlights biotechnology management strategies, and examines biotechnology product development by research institutes and the pharmaceutical industry. The book concludes with an insightful exploration of biotechnology's exciting future.

• Presents evaluation methods for biotechnology-derived products, including characterization of expression vectors and rDNA products, physico-chemical characterization of rDNA proteins, and biological tests for identity and potency
• Combines data and facts with personal anecdotes for reading ease
• Spotlights key targets of inspection and regulatory action, including manufacturing operations, major equipment and facilities, manufacturing records, and quality assurance
• Discusses the use of recombinant DNA technology, chemical synthesis, and immunological methods in vaccine development
• Includes two extensive appendices highlighting summary basis of approval for important vaccines

The Author
Foreword

Chapter 1 : Introduction
Chapter 2 : Regulatory Aspects of the Development of Drugs and Biologics
Chapter 3 : Strategies and Management
Chapter 4 : Research Institutes and the Biotechnology Industry
Chapter 5 : Product Development by Research Institutes and the Pharmaceutical Industry
Chapter 6 : Future Perspective : Optimism, Despite It All

Appendix A : Summary Basis of Approval – Diphtheria and Tetanus Toxoids and Pertussis (DTP) Vaccine Adsorbed and Haemophilus b Conjugate Vaccine
Appendix B : Summary Basis of Approval – Recombinant Hepatitis B Vaccine
Index