With its focus on industrial pharmaceutical research, written by international experts from the industry, this book fills in a gap in the existing literature. It reflects the combination of such pharmaceutical interests as drug delivery, drug targeting, quality and safety management, drug approval and regulation, patenting issues and biotechnology fundamentals.
 

Thus it provides practitioners in pharmaceutical biotechnology with all the relevant information from the shelf.
 

The first part offers a comprehensive survey and review of the rapidly increasing array of biopharmaceuticals derived from the molecular biological approaches now widely available. This is followed by an extra section devoted to the very critical patenting and drug regulation issues. The whole is rounded off by detailed monographs of biotechnologically developed drugs that are already on the market.

 

With a foreword of by Robert Langer, Kenneth J Germeshausen Professor of Chemical and Biomedical Engineering at the Massachusetts Institute of Technology. In 2002, he received the Charles Stark Draper Prize, the highest recognition for an engineer. Professor Langer is member of all three national academies - the Institute of Medicine, the National Academy of Engineering, and the National Academy of Sciences:
 

"The book attempts to provide a balanced view of the biotechnological industry and the number of experts from industry sharing their knowledge and experience with the audience gives the book an outstanding value. All contributors provide with each chapter an up-to-date review on key topics in pharmaceutical biotechnology.
 

This work is not only a valuable tool for the industrial expert but also for all pharmacists and scientists from related areas who wish to work with biotech drugs."

Oliver Kayser received his PhD at the Free University Berlin in 1997 following his fellowship at the University of Gainesville, Florida, whereupon he entered the pharmaceutical biotechnology industry. He is currently a lecturer at the Department of Pharmaceutics, Biopharmacy and Biotechnology at the FU Berlin, working on new biotech drugs from natural sources and on the development of drug delivery carriers based on nanosuspension and solid lipid nanoparticle enterprise technologies.

 

Professor Müller is Head of the Department of Pharmaceutical Technology, Biotechnology & Quality Management at the Free University Berlin. His research focuses on solid lipid nanoparticles, nanosuspensions of poorly soluble drugs and drug targeting using the concept of "differential protein adsorption". He obtained his PhD at Kiel University in 1983, and spent 4 years as visiting scientist at the Pharmacy Department, University of Nottingham, UK and 1 year at the Université de Paris-Sud.

List of Contributors.Color Plates.

Part I. Introduction to Concepts and Technologies in Pharmaceutical Biotechnology.

1. A Primer on Pharmaceutical Biotechnology and Industrial Applications (Oliver Kayser, Rainer H. Muller).

2. Procaryotic and Eucaryotic Cells in Biotech Production (Stefan Pelzer, Dirk Hoffmeister, Irmgard Merfort, Andreas Bechthold).

3. Biopharmaceuticals Expressed in Plants (Jorg Knablein

 

Part II. Industrial Development and Production Process.

4. Scientific, Technical and Economic Aspects of Vaccine Research and Development (Jens-Peter Gregersen).

5. DNA Vaccines: from Research Tools in Mice to Vaccines for Humans (Jeffrey Ulmer, John Donnelly, Jens-Peter Gregersen).

6. Characterization and Bioanalytical Aspects of Recombinant Proteins as Pharmaceutical Drugs (Jutta Haunschild, Titus Kretzschmar).

7. Biogeneric Drugs (Walter Hinderer).

 

Part III. Therapeutic Proteins - Special Pharmaceutical Aspects.

8. Pharmacokinetics and Pharmacodynamics of Biotech Drugs (Bernd Meibohm, Hartmut Derendorf).

9 Formulation of Biotech Products (Ralph Lipp, Erno Pungor).

10. Patents in the Pharmaceutical Biotechnology Industry: Legal and Ethical Issues (David B. Resnik).

11. Drug Approval in the European Union and the United States (Gary Walsh).

 

Part IV. Biotech 21 - Into the Next Decade.

12. Rituximab: Clinical Development of the First Therapeutic Antibody for Cancer (Antonio J. Grillo-Lopez).

13. Somatic Gene Therapy - Advanced Biotechnology Products in Clinical Development (Matthias Schweizer, Egbert Flory, Carsten Muenk, Klaus Cichutek, Uwe Gottschalk).

14. Nonviral Gene Transfer Systems in Somatic Gene Therapy (Oliver Kayser, Albrecht F. Kiderlen).

15. Xenotransplanation in Pharmaceutical Biotechnology (Gregory J. Brunn, Jeffrey L. Platt).

16. Sculpturing the Architecture of Mineralized Tissues: Tissue Engineering of Bone from Soluble Signals to Smart Biomimetic Matrices (Ugo Ripamonti, Lentsha Nathaniel Ramoshebi, Janet Patton, June Teare, Thato Matsaba, Louise Renton).

 

Index.