From the Preface

At the time of this writing, the American biotechnology and pharmaceutical industry has more than two dozen biotechnology-derived therapeutic proteins on the market, while several hundred are in various stages of human clinical trials or at the FDA for review. Today, more than a thousand companies are involved in biotechnology research, with a total revenue of $7.7 billion for 1993. Therapeutic peptides and proteins are expected to mitigate suffering in coming years as anticancer agents, hormones, growth factors, analgesics, anti-hypertensives, and thrombolytics, among others. However, the clinical application of these therapeutic peptides and proteins is limited by several problems, such as lack of physical and chemical stability or the lack of desirable attributes for adequate absorption or distribution. Thus, as these therapeutic peptides and proteins are made available, it will be essential to formulate these drugs into safe, stable and efficacious delivery systems. The pharmaceutical scientist involved in this effort needs to call upon the knowledge of several disciplines, such as pharmaceutics, medicinal chemistry, biochemistry, and microbiology, and needs to keep abreast with the latest research in the published literature. This book presents these principles in a simple, interesting and practically useful manner for the benefit of scientists working in this area and to further research in this area. This book will also provide useful information for students and academic researchers and add to their interest in this area. The book should also be useful in a hospital setting to understand potential physicochemical stability problems that may result during reconstitution or administration of the new recombinant proteins. Since this field is relatively new and rapidly evolving, efforts were made to include very recent literature in the book. As a result, over 40% of the literature citations in the book are for the work published in the last two years.