Novel Therapeutics From Modern Biotechnology: From Laboratory To Human Testing (handbook Of Experimental Pharmacology) (volume 137)

A cover story of Business Week Magazine in January 1984 stated "Biotech Comes of Age". In February 1986, Venture Magazine had a cover article entitled "The Biotech Revolution is Here". This article went on to say "New Genetic Technologies Will Transform Our Lives". These announcements were made many years after the first biotechnology companies, such as Genentech, Cetus, Amgen and Biogen, were formed-to commercialize the "New Biology". . At the time of writing this book, there are over 1300 biotech companies developing new technologies or identifying potential biotech drugs. Most of these companies were started in the height of the "high-technology hype", although companies are still forming as the technology advances. A more recent survey showed only a relatively small number of Food and Drug Administration (FDA) approvals among over several hundred biotech­ nology products now in clinical trial. One could ask why it has taken so long to produce biotechnology products. Part of the reason is that each new class of biotech products brings with it a set of problems that need to be solved before they enter clinical trials. These problems are often unique to biotechnology products, such as peptides, proteins, monoclonal antibodies, nucleic acids and cellular therapies. Front Matter....Pages I-XVII Overview of Regulatory Expectations for Introducing Novel Therapies into Clinical Trials....Pages 1-12 Preparation of Clinical Trial Supplies of Biopharmaceuticals....Pages 13-31 Proteins as Drugs: Analysis, Formulation and Delivery....Pages 33-58 Strategies for Dealing With the Immunogenicity of Therapeutic Proteins....Pages 59-88 Targeted Toxin Hybrid Proteins....Pages 89-110 SB 209763: A Humanized Monoclonal Antibody for the Prophylaxis and Treatment of Respiratory Syncytial Virus Infection....Pages 111-129 Preclinical Development of Antisense Therapeutics....Pages 131-163 Formulation and Delivery of Nucleic Acids....Pages 165-192 Safe, Efficient Production of Retroviral Vectors....Pages 193-219 Clinical Systems for the Production of Cells and Tissues for Human Therapy....Pages 221-241 Back Matter....Pages 243-248

While addressing the particular problems associated with several classes of biotechnology products, this book also demonstrates that the principles are the same as in the development of small new chemical entities. It begins by studying FDA regulatory expectations for biotech products, before moving on to discuss general issues common to each class of biotech drug, such as proteins, peptides, and nucleic acids. The text deals with specific biotech drugs that have successfully made it into clinical trials, and each review is written by a renowned expert in the relevant fields.

Disc. regulatory environment; issues common to peptides, proteins & nucleic acids; clinical trials; quality systems.

This volume addresses the particular problems associated with several classes of biotechnology products, and at the same time demonstrates that the principles are the same as in the development of small new chemical entities. The first chapter addresses FDA regulatory expectations for biotech products. The next several chapters discuss general issues common to each class of biotech drug such as proteins, peptides, and nucleic acids. The balance of the chapters deal with specific biotech drugs that have successfully made it into clinical trials. The reviews are written by renowned experts in their fields