Pharmaceutical Biotechnology: Fundamentals and Applications

ISBN-13: 9781493943395 / Angielski / Miękka / 2016 / 544 str.

Daan J. A. Crommelin; Robert D. Sindelar; Bernd Meibohm

Opis

Updated and expanded in this Fourth Edition with information on oligonucleotides, siRNA, gene therapy and nanotech, this book covers the basic science and the applications of biotechnology-derived pharmaceuticals, with special emphasis on their clinical use.

Spis treści

1: Molecular Biotechnology: From DNA Sequence to Therapeutic Protein.- 2: Biophysical and Biochemical Analysis of Recombinant Proteins.- 3: Production and Purification of Recombinant Proteins.- 4: Formulation of Biotech Products, Including Biopharmaceutical Considerations.- 5: Pharmacokinetics and Pharmacodynamics of Peptide and Protein Therapeutics.- 6: Immunogenicity of Therapeutic Proteins.- 7: Monoclonal Antibodies: From Structure to Therapeutic Application.- 8: Genomics, Other “Omic” Technologies, Personalized Medicine, and Additional Biotechnology-Related Techniques.- 9: Dispensing Biotechnology Products: Handling, Professional Education, and Product Information.- 10: Economic Considerations in Medical Biotechnology.- 11: Regulatory Framework for Biosimilars.- 12: Insulin.- 13: Follicle-Stimulating Hormone.- 14: Human Growth Hormone.- 15: Recombinant Coagulation Factors and Thrombolytic Agents.- 16: Recombinant Human Deoxyribonuclease I.- 17: Monoclonal Antibodies in Cancer.- 18: Hematopoietic Growth Factors: Focus on Erythropoiesis-Stimulating Agents.- 19: Monoclonal Antibodies in Solid Organ Transplantation.- 20: Monoclonal Antibodies and Antibody-Based Biotherapeutics in Inflammatory Diseases.- 21: Interferons and Interleukins.- 22: Vaccines.-  23: Oligonucleotides.- 24: Gene Therapy.- 25: Stem Cell Technology

O autorze

DAAN J.A. CROMMELIN is Professor at the Department of Pharmaceutics at Utrecht University. Until December 2011 he was scientific director of the Dutch Top Institute Pharma in Leiden. He is adjunct professor at the Department of Pharmaceutics and Pharmaceutical Chemistry at the University of Utah. Dr. Crommelin is co-founder of OctoPlus, a Leiden based company specialized in the development of pharmaceutical product formulations and advanced drug delivery systems. He published over 335 articles and has held leadership positions at the International Pharmaceutical Federation (FIP) and the European Federation for Pharmaceutical Sciences (EUFEPS).

ROBERT D. SINDELAR is currently President, The Providence Health Care Research Institute, Vice President Research and Academic, Providence Health Care (part of the British Columbia public health care system), Professor Faculty of Pharmaceutical Sciences and Associate Dean Research Faculty of Medicine The University of British Columbia (UBC).  He served for 11 years as Dean and Professor, The UBC Faculty of Pharmaceutical Sciences following 19 years at the University of Mississippi where he held the positions of Professor and Chair of Medicinal Chemistry, School of Pharmacy and served as Interim Dean.  Dr. Sindelar’s expertise lies in medicinal chemistry, computer-aided drug discovery and design, pharmaceutical biotechnology, and creating opportunities to integrate innovation into the health care system. 

BERND MEIBOHM is Professor of Pharmaceutical Sciences and Associate Dean for Research and Graduate Programs at the University of Tennessee College of Pharmacy in Memphis. His area of expertise lies in clinical pharmacology and pharmacokinetic/pharmacodynamics correlations. Dr. Meibohm obtained his doctoral degree in Pharmaceutics from the Technical University Carolo-Wilhelmina, Braunschweig, Germany and received postdoctoral training at the University of Florida, Gainesville. Dr. Meibohm is a fellow of the American Association of Pharmaceutical Scientists and the American College of Clinical Pharmacology, and has published three textbooks, more than 90 peer-reviewed research articles and book chapters, 130 abstracts, and over 100 invited scientific presentations to national and international audiences.

Blurb

Setting the standard for modern biopharmaceutical education, the new Fourth Edition is a completely revised text to reflect the rapid growth in the importance of biopharmaceuticals and the techniques of biotechnologies to modern medicine and the life sciences.  The editors have provided a well-balanced framework for introductory as well as more detailed education in various aspects of pharmaceutical biotechnology and the production, biopharmaceutics, and clinical pharmacology of biotechnology-produced drugs.  The new edition improves upon the strong chapters of previous editions, adding emergent trends and cutting-edge advances as well as new graphic illustrations and new authors.  The textbook includes key concepts at the foundation of the technology relevant for protein therapeutics including molecular biology, production and analysis procedures, formulation development, pharmacokinetics and pharmacodynamics, and immunogenicity, as well as chapters dealing with regulatory, economic, and pharmacy practice considerations.

 

The Fourth Edition brings an exciting and fundamental reorganization of the text, now structured into two sections: 1) an initial basic science and general features section; and 2) a section profiling the various therapeutic classes of biologics, including gene therapy.  Additionally, reorganization of the chapters examining the properties and applications of monoclonal antibodies, and oligonucleotides and siRNA has enhanced these important concepts in the text.  A completely new chapter has been added on cell-based technologies.

 

The Fourth Edition continues the popular self-assessment questions after each chapter to reinforce understanding of practical pharmaceutical applications, making this an indispensable text for self-study, the biopharmaceutical classroom, as well as for professional reference in practice or industry.