Biopharmaceuticals An Industrial Perspective PDF Download
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| Author | : G. Walsh |
| Publisher | : Springer Science & Business Media |
| Total Pages | : 515 |
| Release | : 2013-03-09 |
| Genre | : Science |
| ISBN | : 9401709262 |
Download Biopharmaceuticals, an Industrial Perspective Book in PDF, ePub and Kindle
This book provides a unique and up-to-date insight into the biopharmaceutical industry. Largely written by industrial authors, its scope is multidisciplinary, rendering it an ideal reference source for students undertaking advanced undergraduate or postgraduate courses in biotechnology, pharmaceutical science, biochemistry, or medicine.
| Author | : Walsh |
| Publisher | : |
| Total Pages | : 524 |
| Release | : 2009-08-01 |
| Genre | : |
| ISBN | : 9788184892932 |
Download Biopharmaceuticals, An Industrial Perspective Book in PDF, ePub and Kindle
| Author | : Rachel Kim |
| Publisher | : Routledge |
| Total Pages | : 142 |
| Release | : 2018-12-17 |
| Genre | : Business & Economics |
| ISBN | : 135101269X |
Download Economics and Management in the Biopharmaceutical Industry in the USA Book in PDF, ePub and Kindle
From a managerial perspective, the biopharmaceutical industry represents a competitive, fast-changing, intellectually-powered, innovation-driven sector. Many management scholars have studied this discontinuous era to make sense of strategic behavior and the cognition of firms and top managers. A past look at the biopharmaceutical industry provides answers to questions that most managers have. For example, what options do you have and what actions do you take when new firms enter your industry? In the 1970s, new biotechnology firms, funded by venture capitalists, appeared in the pharmaceutical industry with new knowledge. Successful pharmaceutical firms decided to collaborate with the new entrants and forge relationships to develop and create new, biotechnology engineered drugs. Thus, the addition of new biotechnology firms ushered in a new business model based on strategic alliances. Strategic alliances have now become an industrial norm called open innovation. The author looks at the historical path of the biopharmaceutical industry, particularly in the United States. While the pharmaceutical industry’s main contributions to society are substantial, there are pressing challenges the industry must face, such as an increase in infectious disease outbreaks or the global aging population, which require new types of care, additionally, mental health care and prescription painkiller addiction are persistent issues with economic repercussions to both federal and local governments. This book presents a holistic view of the biopharmaceutical industry, putting it in a historical context. It will best serve those who are eager to learn about this dynamic, fast-evolving industry and who would like to tackle current biopharmaceutical industry issues in the United States and be prepared for future industry challenges.
| Author | : Nuala Calnan |
| Publisher | : CRC Press |
| Total Pages | : 357 |
| Release | : 2017-06-26 |
| Genre | : Medical |
| ISBN | : 1315351366 |
Download A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry Book in PDF, ePub and Kindle
This book addresses the rapidly emerging field of Knowledge Management in the pharmaceutical, medical devices and medical diagnostics industries. In particular, it explores the role that Knowledge Management can play in ensuring the delivery of safe and effective products to patients. The book also provides good practice examples of how the effective use of an organisation’s knowledge assets can provide a path towards business excellence.
| Author | : Adalberto Pessoa |
| Publisher | : CRC Press |
| Total Pages | : 400 |
| Release | : 2021-07-16 |
| Genre | : Medical |
| ISBN | : 1000399842 |
Download Pharmaceutical Biotechnology Book in PDF, ePub and Kindle
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.
| Author | : Irina Haracoglou |
| Publisher | : |
| Total Pages | : 286 |
| Release | : 2005 |
| Genre | : Patent laws and legislation |
| ISBN | : |
Download The Duty to Deal in the Biopharmaceutical Industry Book in PDF, ePub and Kindle
| Author | : National Research Council |
| Publisher | : National Academies Press |
| Total Pages | : 158 |
| Release | : 2015-06-29 |
| Genre | : Science |
| ISBN | : 0309316553 |
Download Industrialization of Biology Book in PDF, ePub and Kindle
The tremendous progress in biology over the last half century - from Watson and Crick's elucidation of the structure of DNA to today's astonishing, rapid progress in the field of synthetic biology - has positioned us for significant innovation in chemical production. New bio-based chemicals, improved public health through improved drugs and diagnostics, and biofuels that reduce our dependency on oil are all results of research and innovation in the biological sciences. In the past decade, we have witnessed major advances made possible by biotechnology in areas such as rapid, low-cost DNA sequencing, metabolic engineering, and high-throughput screening. The manufacturing of chemicals using biological synthesis and engineering could expand even faster. A proactive strategy - implemented through the development of a technical roadmap similar to those that enabled sustained growth in the semiconductor industry and our explorations of space - is needed if we are to realize the widespread benefits of accelerating the industrialization of biology. Industrialization of Biology presents such a roadmap to achieve key technical milestones for chemical manufacturing through biological routes. This report examines the technical, economic, and societal factors that limit the adoption of bioprocessing in the chemical industry today and which, if surmounted, would markedly accelerate the advanced manufacturing of chemicals via industrial biotechnology. Working at the interface of synthetic chemistry, metabolic engineering, molecular biology, and synthetic biology, Industrialization of Biology identifies key technical goals for next-generation chemical manufacturing, then identifies the gaps in knowledge, tools, techniques, and systems required to meet those goals, and targets and timelines for achieving them. This report also considers the skills necessary to accomplish the roadmap goals, and what training opportunities are required to produce the cadre of skilled scientists and engineers needed.
| Author | : National Academies of Sciences, Engineering, and Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 69 |
| Release | : 2019-04-05 |
| Genre | : Medical |
| ISBN | : 0309487811 |
Download Continuous Manufacturing for the Modernization of Pharmaceutical Production Book in PDF, ePub and Kindle
On July 30-31, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Continuous Manufacturing for the Modernization of Pharmaceutical Production. This workshop discussed the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics such as enzymes, monoclonal antibodies, and vaccines. The participants also discussed specific challenges for integration across the manufacturing system, including upstream and downstream processes, analytical techniques, and drug product development. The workshop addressed these challenges broadly across the biologics domain but focused particularly on drug categories of greatest FDA and industrial interest such as monoclonal antibodies and vaccines. This publication summarizes the presentations and discussions from the workshop.
| Author | : Ming-Kung Yeh |
| Publisher | : BoD – Books on Demand |
| Total Pages | : 140 |
| Release | : 2018-09-19 |
| Genre | : Medical |
| ISBN | : 1789237181 |
Download Biopharmaceuticals Book in PDF, ePub and Kindle
Biopharmaceuticals are derived from biological sources, either live organisms or their active components; nowadays, they are mainly produced by biotechnologies. Biopharmaceuticals are extensively used in the treatment of various diseases such as cardiovascular, metabolic, neurological diseases, cancer, and others for which there are no available therapeutic methods. With the advance of science, biopharmaceuticals have revolutionized the treatment, prevention, and diagnosis of many patients with disabling and life-threatening diseases. Innovative biopharmaceuticals definitely improve the life quality of patients and enhance the effectiveness of the healthcare system. This book encompasses the discovery, production, application, and regulation of biopharmaceuticals to demonstrate their research achievement, prospects, and challenges. We expect the significance of biopharmaceuticals to be revealed and emphasized by this book.
| Author | : John Geigert |
| Publisher | : Springer |
| Total Pages | : 426 |
| Release | : 2019-05-08 |
| Genre | : Medical |
| ISBN | : 3030137546 |
Download The Challenge of CMC Regulatory Compliance for Biopharmaceuticals Book in PDF, ePub and Kindle
Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products. These biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the CMC strategy and regulatory compliance requirements for these challenging products. Companies clearly plan out the strategy for their clinical study plans, but frequently, the development of a strategy for CMC is an afterthought. Coupled with the complexity of the biopharmaceutical manufacturing processes and products, and this can be a recipe for disaster. The third edition of this book provides insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for all biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals.
