This volume focuses on pharmaceutical biotechnology as a key area of life sciences. The complete range of concepts, processes and technologies of biotechnology is applied in modern industrial pharmaceutical research, development and production. The results of genome sequencing and studies of biological-genetic function are combined with chemical, micro-electronic and microsystem technology to produce medical devices and diagnostic biochips. A multitude of biologically active molecules is expanded by additional novel structures created with newly arranged gene clusters and bio-catalytic chemical processes. New organisational structures in the co-operation of institutes, companies and networks enable faster knowledge and product development and immediate application of the results of research and process development. This book is the ideal source of information for scientists and engineers in research and development, for decision-makers in biotech, pharma and chemical corporations, as well as for research institutes, but also for founders of biotech companies and people working for venture capital corporations.

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 Sciences.

Pharmaceutical Biotechnology offers students taking Pharmacy and related Medical and Pharmaceutical courses a comprehensive introduction to the fast-moving area of biopharmaceuticals. With a particular focus on the subject taken from a pharmaceutical perspective, initial chapters offer a broad introduction to protein science and recombinant DNA technology- key areas that underpin the whole subject. Subsequent chapters focus upon the development, production and analysis of these substances. Finally the book moves on to explore the science, biotechnology and medical applications of specific biotech products categories. These include not only protein-based substances but also nucleic acid and cell-based products. introduces essential principles underlining modern biotechnology- recombinant DNA technology and protein science an invaluable introduction to this fast-moving subject aimed specifically at pharmacy and medical students includes specific ‘product category chapters’ focusing on the pharmaceutical, medical and therapeutic properties of numerous biopharmaceutical products. entire chapter devoted to the principles of genetic engineering and how these drugs are developed. includes numerous relevant case studies to enhance student understanding no prior knowledge of protein structure is assumed

Pharmaceutical Biotechnology: A Focus on Industrial Application covers the development of new biopharmaceuticals as well as the improvement of those being produced. The main purpose is to provide background and concepts related to pharmaceutical biotechnology, together with an industrial perspective. This is a comprehensive text for undergraduates, graduates and academics in biochemistry, pharmacology and biopharmaceutics, as well as professionals working on the interdisciplinary field of pharmaceutical biotechnology. Written with educators in mind, this book provides teachers with background material to enhance their classes and offers students and other readers an easy-to-read text that examines the step-by-step stages of the development of new biopharmaceuticals. Features: Discusses specific points of great current relevance in relation to new processes as well as traditional processes Addresses the main unitary operations used in the biopharmaceutical industry such as upstream and downstream Includes chapters that allow a broad evaluation of the production process Dr. Adalberto Pessoa Jr. is Full Professor at the School of Pharmaceutical Sciences of the University of São Paulo and Visiting Senior Professor at King’s College London. He has experience in enzyme and fermentation technology and in the purification processes of biotechnological products such as liquid–liquid extraction, cross-flow filtration and chromatography of interest to the pharmaceutical and food industries. Dr. Michele Vitolo is Full Professor at the School of Pharmaceutical Sciences of the University of São Paulo. He has experience in enzyme technology, in immobilization techniques (aiming the reuse of the biocatalyst) and in the operation of membrane reactors for obtaining biotechnological products of interest to the pharmaceutical, chemical and food industries. Dr. Paul F. Long is Professor of Biotechnology at King's College London and Visiting International Research Professor at the University of São Paulo. He is a microbiologist by training and his research uses a combination of bioinformatics, laboratory and field studies to discover new medicines from nature, particularly from the marine environment.

This introductory text explains both the basic science and the applications of biotechnology-derived pharmaceuticals, with special emphasis on their clinical use. It serves as a complete one-stop source for undergraduate/graduate pharmacists, pharmaceutical science students, and for those in the pharmaceutical industry. The Fifth Edition completely updates the previous edition, and also includes additional coverage on the newer approaches such as oligonucleotides, siRNA, gene therapy and nanotech and enzyme replacement therapy.

This book describes the way that pharmaceutical projects and programs are currently managed, and offers views from many highly experienced practitioners from within the industry on future directions for drug program management. The book integrates portfolio, program, and project management processes as fundamental for effective and efficient drug product development. Contributing expert authors provide their view of how the projectization approach can be taken forward by the drug industry over the coming years.

The field of pharmaceutical biotechnology is evolving rapidly. A whole new arsenal of protein pharmaceuticals is being produced by recombinant techniques for cancer, viral infections, cardiovascular and hereditary disorders, and other diseases. In addition, scientists are confronted with new technologies such as polymerase chain reactions, combinatorial chemistry and gene therapy. This introductory textbook provides extensive coverage of both the basic science and the applications of biotechnology-produced pharmaceuticals, with special emphasis on their clinical use. Pharmaceutical Biotechnology serves as a complete one-stop source for undergraduate pharmacists, and it is valuable for researchers and professionals in the pharmaceutical industry as well.

This book explains both the basic science and the applications of biotechnology-derived pharmaceuticals, with special emphasis on their clinical uses. The foundations of pharmaceutical biotechnology lie mainly in the capability of plants, microorganism, and animals to produce low and high molecular weight compounds useful as therapeutics. Pharmaceutical biotechnology has flourished since the advent of recombinant DNA technology and metabolic engineering, supported by the well-developed bioprocess technology. A large number of monoclonal antibodies and therapeutic proteins have been approved, delivering meaningful contributions to patients’ lives, and the techniques of biotechnology are also a driving force in modern drug discovery. Due to this rapid growth in the importance of biopharmaceuticals and the techniques of biotechnologies to modern medicine and the life sciences, the field of pharmaceutical biotechnology has become an increasingly important component in the education of pharmacists and pharmaceutical scientists. This book will serve as a complete one-stop source on the subject for undergraduate and graduate pharmacists, pharmaceutical science students, and pharmaceutical scientists in industry and academia.

Stay up to date with changes in the biopharmaceutical products market! With the growth rate of biopharmaceutical products ascending rapidly since the 1980s, the number of biotechnology companies has risen to more than 1200 new businesses in the Unites States alone. This dramatic increase creates a new set of challenges in education, putting demands on teachers and students to keep pace with innovations in terminology and techniques. The Handbook of Pharmaceutical Biotechnology is essential in meeting those challenges. A practical compendium of biotechnology-produced drugs, the Handbook of Pharmaceutical Biotechnology covers general principles of biotechnology and pharmaceuticals, putting usable information in the hands of those who need it most. The book presents descriptions that break down each pharmaceutical product by pharmacology, pharmacokinetics, clinical applications, toxicities, and dosage guidelines. It also reviews prescription products, discussing clinical uses and trials, adverse reactions, and more. Tables, figures, and extensive references add to each comprehensive summary. The Handbook of Pharmaceutical Biotechnology also includes up-to-date information on: monoclonal antibodies (Abciximab, Muromonab-CD3) enzymes and regulators of enzyme activity (Alteplase, clotting factors, Dornase alpha) anticytokines olgonucleotide and gene therapy hematopoietic growth factors (interleukins, interferons, colony stimulating factors, erythropoietin) As the worldwide production and sales of biotechnology-derived pharmaceuticals and diagnostics continues to grow, teachers, students, and clinical pharmacists need to maintain a clear and current understanding of the field. The Handbook of Pharmaceutical Biotechnology presents a thoughtful and thorough guide to keeping pace in this evolving industry.