2nd Edition. — Wiley, 2012. — 658 p.This second edition of a very successful book is thoroughly updated with existing chapters completely rewritten while the content has more than doubled from 16 to 36 chapters. As with the first edition, the focus is on industrial pharmaceutical research, written by a team of industry experts from around the world, while quality and safety management, drug approval and regulation, patenting issues, and biotechnology fundamentals are also covered. In addition, this new edition now not only includes biotech drug development but also the use of biopharmaceuticals in diagnostics and vaccinations. With a foreword by Robert Langer, Kenneth J germeshausen Professor of Chemical and Biomedical Engineering at Mit and member of the National Academy of Engineering and the National Academy of SciencesContents
Concepts and Methods for Recombinant Drug Production
Pharmaceutical Biotechnology and Industrial Applications – Learning Lessons from Molecular Biology
Prokaryotic Cells in Biotech Production
Mammalian Cells in Biotech Production
Biopharmaceuticals from Plants
Production of Biopharmaceuticals in Transgenic Animals
Translation of New Technologies in Biomedicines: Shaping the Road from Basic Research to Drug Development and Clinical Application – and Back Again
Bringing the Drug into Action – From Downstreaming to Approval
Overview and Classification of Approved Recombinant Drugs
Downstream Processing
Characterization of Recombinant Proteins
Formulation Strategies for Recombinant Protein and Related Biotech Drugs
Drug Approval in the European Union and United States
Patents in the Pharmaceutical Biotechnology Industry: Legal and Ethical Issues
Biosimilar Drugs
Pharmacokinetics and Pharmacodynamics of Therapeutic Peptides and Proteins
Vaccines
Scientific, Technical, and Economic Aspects of Vaccine Research and Development
New Nanobiotechnological Strategies for the Development of Vectors for Cancer Vaccines
Recombinant Vaccines: Development, Production, and Application
Recent Applications in Pharmaceutical Biotechnology
In silico and Ultrahigh-Throughput Screenings (uHts) in Drug Discovery: an Overview 19 Metabolic Engineering of Medicinal Plants and Microorganisms for the Production of Natural Products
Metabolomics as a Bioanalytical Tool for Characterization of Medicinal Plants and Their Phytomedical Preparations
Integration of Biotechnologies for the Development of Personalized Medicine
Xenotransplantation in Pharmaceutical Biotechnology
Nutraceuticals–Functional Foods for Improving Health and Preventing Disease
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