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Biopharmaceuticals An Industrial Perspective
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Book Synopsis Biopharmaceuticals, an Industrial Perspective by : G. Walsh
Download or read book Biopharmaceuticals, an Industrial Perspective written by G. Walsh and published by Springer Science & Business Media. This book was released on 2013-03-09 with total page 515 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Biopharmaceuticals, An Industrial Perspective by : Walsh
Download or read book Biopharmaceuticals, An Industrial Perspective written by Walsh and published by . This book was released on 2009-08-01 with total page 524 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Economics and Management in the Biopharmaceutical Industry in the USA by : Rachel Kim
Download or read book Economics and Management in the Biopharmaceutical Industry in the USA written by Rachel Kim and published by Routledge. This book was released on 2018-12-17 with total page 142 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry by : Nuala Calnan
Download or read book A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry written by Nuala Calnan and published by CRC Press. This book was released on 2017-06-26 with total page 516 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Pharmaceutical Biotechnology by : Adalberto Pessoa
Download or read book Pharmaceutical Biotechnology written by Adalberto Pessoa and published by CRC Press. This book was released on 2021-07-16 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Filtration and Purification in the Biopharmaceutical Industry, Third Edition by : Maik W. Jornitz
Download or read book Filtration and Purification in the Biopharmaceutical Industry, Third Edition written by Maik W. Jornitz and published by CRC Press. This book was released on 2019-06-26 with total page 673 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since sterile filtration and purification steps are becoming more prevalent and critical within medicinal drug manufacturing, the third edition of Filtration and Purification in the Biopharmaceutical Industry greatly expands its focus with extensive new material on the critical role of purification and advances in filtration science and technology. It provides state-of-the-science information on all aspects of bioprocessing including the current methods, processes, technologies and equipment. It also covers industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries. The book is an essential, comprehensive source for all involved in filtration and purification practices, training and compliance. It describes such technologies as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration. Features: Addresses recent biotechnology-related processes and advanced technologies such as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration of medium, buffer and end product Presents detailed updates on the latest FDA and EMA regulatory requirements involving filtration and purification practices, as well as discussions on best practises in filter integrity testing Describes current industry quality standards and validation requirements and provides guidance for compliance, not just from an end-user perspective, but also supplier requirement It discusses the advantages of single-use process technologies and the qualification needs Sterilizing grade filtration qualification and process validation is presented in detail to gain the understanding of the regulatory needs The book has been compilated by highly experienced contributors in the field of pharmaceutical and biopharmaceutical processing. Each specific topic has been thoroughly examined by a subject matter expert.
Book Synopsis Pharmaceutical Biotechnology by : Gary Walsh
Download or read book Pharmaceutical Biotechnology written by Gary Walsh and published by John Wiley & Sons. This book was released on 2013-04-25 with total page 499 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis Biopharmaceuticals by : Ming-Kung Yeh
Download or read book Biopharmaceuticals written by Ming-Kung Yeh and published by BoD – Books on Demand. This book was released on 2018-09-19 with total page 140 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Rare Disease Drug Development by : Raymond A. Huml
Download or read book Rare Disease Drug Development written by Raymond A. Huml and published by Springer Nature. This book was released on 2021-11-08 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a broad overview of rare disease drug development. It offers unique insights from various perspectives, including third-party capital providers, caregivers, patient advocacy groups, drug development professionals, marketing and commercial experts, and patients. A unique reference, the book begins with narratives on the many challenges faced by rare disease patient and their caregivers. Subsequent chapters underscore the critical, multidimensional role of patient advocacy groups and the novel approaches to related clinical trials, investment decisions, and the optimization of rare disease registries. The book addresses various rare disease drug development processes by disciplines such as oncology, hematology, pediatrics, and gene therapy. Chapters then address the operational aspects of drug development, including approval processes, development accelerations, and market access strategies. The book concludes with reflections on the authors' case for real-world data and evidence generation in orphan medicinal drug development. Rare Disease Drug Development is an expertly written text optimized for biopharmaceutical R&D experts, commercial experts, third-party capital providers, patient advocacy groups, patients, and caregivers.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309468086 Total Pages :235 pages Book Rating :4.3/5 (94 download)
Book Synopsis Making Medicines Affordable by : National Academies of Sciences, Engineering, and Medicine
Download or read book Making Medicines Affordable written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-03-01 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.
Book Synopsis The Challenge of CMC Regulatory Compliance for Biopharmaceuticals by : John Geigert
Download or read book The Challenge of CMC Regulatory Compliance for Biopharmaceuticals written by John Geigert and published by Springer. This book was released on 2019-05-08 with total page 426 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Biopharmaceuticals written by Gary Walsh and published by John Wiley & Sons. This book was released on 2013-04-29 with total page 544 pages. Available in PDF, EPUB and Kindle. Book excerpt: The latest edition of this highly acclaimed textbook, provides a comprehensive and up-to-date overview of the science and medical applications of biopharmaceutical products. Biopharmaceuticals refers to pharmaceutical substances derived from biological sources, and increasingly, it is synonymous with 'newer' pharmaceutical substances derived from genetic engineering or hybridoma technology. This superbly written review of the important areas of investigation in the field, covers drug production, plus the biochemical and molecular mechanisms of action together with the biotechnology of major biopharmaceutical types on the market or currently under development. There is also additional material reflecting both the technical advances in the area and detailed information on key topics such as the influence of genomics on drug discovery.
Book Synopsis Pharmaceutical Quality by Design by : Sarwar Beg
Download or read book Pharmaceutical Quality by Design written by Sarwar Beg and published by Academic Press. This book was released on 2019-03-27 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers Includes contributions from global leaders and experts from academia, industry and regulatory agencies
Book Synopsis Industrialization of Biology by : National Research Council
Download or read book Industrialization of Biology written by National Research Council and published by National Academies Press. This book was released on 2015-06-29 with total page 167 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Business Development for the Biotechnology and Pharmaceutical Industry by : Martin Austin
Download or read book Business Development for the Biotechnology and Pharmaceutical Industry written by Martin Austin and published by CRC Press. This book was released on 2016-04-08 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt: Business Development in the biotechnology and pharmaceutical industries accounts for over $5 billion in licensing deal value per year and much more than that in the value of mergers and acquisitions. Transactions range from licences to patented academic research, to product developments as licences, joint ventures and acquisition of intellectual property rights, and on to collaborations in development and marketing, locally or across the globe. Asset sales, mergers and corporate takeovers are also a part of the business development remit. The scope of the job can be immense, spanning the life-cycle of products from the earliest levels of research to the disposal of residual marketing rights, involving legal regulatory manufacturing, clinical development, sales and marketing and financial aspects. The knowledge and skills required of practitioners must be similarly broad, yet the availability of information for developing a career in business development is sparse. Martin Austin's highly practical guide spans the complete process and is based on his 30 years of experience in the industry and the well-established training programme that he has developed and delivers to pharmaceutical executives from across the world.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309487811 Total Pages :69 pages Book Rating :4.3/5 (94 download)
Book Synopsis Continuous Manufacturing for the Modernization of Pharmaceutical Production by : National Academies of Sciences, Engineering, and Medicine
Download or read book Continuous Manufacturing for the Modernization of Pharmaceutical Production written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-04-05 with total page 69 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Developability of Biotherapeutics by : Sandeep Kumar
Download or read book Developability of Biotherapeutics written by Sandeep Kumar and published by CRC Press. This book was released on 2015-11-18 with total page 297 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biopharmaceuticals are emerging as frontline medicines to combat several life-threatening and chronic diseases. However, such medicines are expensive to develop and produce on a commercial scale, contributing to rising healthcare costs. Developability of Biotherapeutics: Computational Approaches describes applications of computational and molecular modeling techniques that improve the overall process of discovery and development by removing empiricism. The concept of developability involves making rational choices at the pre-clinical stages of biopharmaceutical drug development that could positively impact clinical outcomes. The book also addresses a general lack of awareness of the many different contributions that computation can make to biopharmaceutical drug development. This informative and practical reference is a valuable resource for professionals engaged in industrial research and development, scientists working with regulatory agencies, and pharmacy, medicine, and life science students and educators. It focuses primarily on the developability of monoclonal antibody candidates, but the principles described can also be extended to other modalities such as recombinant proteins, fusion proteins, antibody drug conjugates and vaccines. The book is organized into two sections. The first discusses principles and applications of computational approaches toward discovering and developing biopharmaceutical drugs. The second presents best practices in developability assessments of early-stage biopharmaceutical drug candidates. In addition to raising awareness of the promise of computational research, this book also discusses solutions required to improve the success rate of translating biologic drug candidates into products available in the clinic. As such, it is a rich source of information on current principles and practices as well as a starting point for finding innovative applications of computation towards biopharmaceutical drug development.
