Pharmaceutical Biotechnology

Pharmaceutical Biotechnology is a unique compilation of reviews addressing frontiers in biologicals as a rich source for innovative medicines. This book fulfills the needs of a broad community of scientists interested in biologicals from diverse perspectives—basic research, biotechnology, protein engineering, protein delivery, medicines, pharmaceuticals and vaccinology. The diverse topics range from advanced biotechnologies aimed to introduce novel, potent engineered vaccines of unprecedented efficacy and safety for a wide scope of human diseases to natural products, small peptides and polypeptides engineered for discrete prophylaxis and therapeutic purposes. Modern biologicals promise to dramatically expand the scope of preventive medicine beyond the infectious disease arena into broad applications in immune and cancer treatment, as exemplified by anti-EGFR receptors antibodies for the treatment of breast cancer. The exponential growth in biologicals such as engineered proteins andvaccines has been boosted by unprecedented scientific breakthroughs made in the past decades culminating in an in-depth fundamental understanding of the scientific underpinnings of immune mechanisms together with knowledge of protein and peptide scaffolds that can be deliberately manipulated. This has in turn led to new strategies and processes. Deciphering the human, mammalian and numerous pathogens’ genomes provides opportunities that never before have been available—identification of discrete antigens (genomes and antigenomes) that lend themselves to considerably improved antigens and monoclonal antibodies, which with more sophisticated engineered adjuvants and agonists of pattern recognition receptors present in immune cells, deliver unprecedented safety and efficacy. Technological development such a nanobiotechnologies (dendrimers, nanobodies and fullerenes), biological particles (viral-like particles and bacterial ghosts) and innovative vectors (replication-competent attenuated,replication-incompetent recombinant and defective helper-dependent vectors) fulfill a broad range of cutting-edge research, drug discovery and delivery applications. Most recent examples of breakthrough biologicals include the human papilloma virus vaccine (HPV, prevention of women genital cancer) and the multivalent Pneumoccocal vaccines, which has virtually eradicated in some populations a most prevalent bacterial ear infection (i.e., otitis media). It is expected that in the years to come similar success will be obtained in the development of vaccines for diseases which still represent major threats for human health, such as AIDS, as well as for the generation of improved vaccines against diseases like pandemic flu for which vaccines are currently available. Furthermore, advances in comparative immunology and innate immunity revealed opportunities for innovative strategies for ever smaller biologicals and vaccines derived from species such as llama and sharks, which carry tremendous potential for innovative biologicals already in development stages in many pharmaceutical companies. Such recent discoveries and knowledge exploitations hold the promise for breakthrough biologicals, with the coming decade. Finally, this book caters to individuals not directly engaged in the pharmaceutical drug discovery process via a chapter outlining discovery, preclinical development, clinical development and translational medicine issues that are critical the drug development process.

The authors and editors hope that this compilation of reviews will help readers rapidly and completely update knowledge and understanding of the frontiers in pharmaceutical biotechnologies.

Carlos A. Guzmán, MD, PhD is Head of the Department of Vaccinology and Applied Microbiology at the Helmholtz Centre for Infection Research (Braunschweig, Germany) and APL-Professor at the Medical School of Hannover. He is also German Coordinator for the International Doctorate in “Experimental Oncology” and Chair for “Vaccines & Antiinfectives” from the Indo-German Science Centre for Infectious Diseases. He graduated in Medicine at the National University of Rosario and obtained his Board Certification in Medical Bacteriology in Argentina. Then he moved to the Institute of Microbiology at the University of Genoa (Italy), as Research Fellow of the Italian Foreign Office Ministry. In Italy he also graduated as Doctor of Medicine and Surgery and obtained his Doctorate of Research in Microbiological Sciences. In 1994 he moved to Germany, where he became Head of the Vaccine Research Group at the German Research Centre for Biotechnology. He has been working in the field of vaccinology since 1989. His work has been instrumental for the development of new adjuvants, and the establishment of Salmonella spp. as a delivery system for DNA vaccines and therapeutic molecules. He has published more than 150 topic-related papers in international peer-reviewed journals and is co-inventor in several international patents. He is member of the Editorial Boards of Infection and Immunity, Microbial Biotechnology, Open Immunology Journal, Current Immunology Reviews, Open Vaccine Journal and Open Microbiology Journal, and Associate Editor of Human Vaccines.

Giora Z. Feuerstein, MD, MSc, FAHA is Assistant Vice President and Head of Discovery Translational Medicine, Wyeth Research. Prior to joining Wyeth, Dr. Feuerstein has maintained Executive Directorship position in discovery of cardiovascular, stroke, thrombosis and metabolic disease programs for 16 years in SmithKline Beecham,DuPont Pharma and Merck USA. Dr. Feuerstein led the discovery program of Carvedilol (COR EG) for heart failure, eprosartan for hypertension and many development programs in stroke, anti-arrhythmics, thrombosis and metabolic diseases. Dr. Feuerstein serves as Editor, Biochemical Pharmacology, editorial boards of Journal of Pharmacology and Experimental Therapeutics, Journal of Cerebral Blood Flow Metabolism, Circulation Research, and Stroke. Dr. Feuerstein is the recipient of several national and international awards including Award of Excellent in Cardiovascular Research, AHA; Prix Galien Award for Drug Discovery (endothelin antagonist), Conrad R. Lam Award for cardiovascular research, Henry Ford Foundation and Wyeth R&D President award. Giora Feuerstein has authored and coauthored over 400 peer-reviewed publications and is co-inventor on 12 patents.