Written by international experts from within the sector, this is the first book to focus on industrial pharmaceutical research. As such, it responds to the combination of such pharmaceutical interests as drug delivery, drug targeting, quality and safety management, drug approval and regulation, patenting issues and biotechnology fundamentals.

The first part provides 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 highly critical patenting and drug regulation issues. The whole is rounded off by detailed monographs of biotechnologically developed drugs that are already on the market.

In short, Pharmaceutical Biotechnology: Drug Discovery and Clinical Applications provides practitioners in pharmaceutical biotechnology with all the relevant information straight off the shelf.

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.

Contents

1. Introduction to Concepts and Technologies in Pharmaceutical Biotechnology
   1. A Primer on Pharmaceutical Biotechnology and Industrial Applications
   2. Procaryotic and Eucaryotic Cells in Biotech Production
   3. Biopharmaceuticals Expressed in Plants

2. Industrial Development and Production Process
   4. Scientific, Technical and Economic Aspects of Vaccine Research and Development
   5. DNA Vaccines: from Research Tools in Mice to Vaccines for Humans
   6. Characterization and Bioanalytical Aspects of Recombinant Proteins as Pharmaceutical Drugs
   7. Biogeneric Drugs

3. Therapeutic Proteins – Special Pharmaceutical Aspects
   8. Pharmacokinetics and Pharmacodynamics of Biotech Drugs
   9. Formulation of Biotech Products
   10. Patents in the Pharmaceutical Biotechnology Industry: Legal and Ethical Issues
   11. Drug Approval in the European Union and the United States

4. Biotech 21 – Into the Next Decade
   12. Rituximab: Clinical Development of the First Therapeutic Antibody for Cancer
   13. Somatic Gene Therapy – Advanced Biotechnology Products in Clinical Development
   14. Nonviral Gene Transfer Systems in Somatic Gene Therapy
   15. Xenotransplanation in Pharmaceutical Biotechnology
   16. Sculpturing the Architecture of Mineralized Tissues: Tissue Engineering of Bone from Soluble Signals to Smart Biomimetic Matrices

Index

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