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Evaluating Future Biopharmaceutical Inspection Needs Infrastructure Capability Gaps And Technology Development Strategies
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Book Synopsis Evaluating Future Biopharmaceutical Inspection Needs, Infrastructure Capability Gaps, and Technology Development Strategies by : Marnix English Hollander
Download or read book Evaluating Future Biopharmaceutical Inspection Needs, Infrastructure Capability Gaps, and Technology Development Strategies written by Marnix English Hollander and published by . This book was released on 2012 with total page 70 pages. Available in PDF, EPUB and Kindle. Book excerpt: The biotechnology industry is undergoing a paradigm shift in the properties of the manufactured drug product. As therapeutic protein formulations change from agonist to antagonist methods of action, the concentration of proteins in each dose increased by orders of magnitude, and with it, the challenge of producing and inspecting the product. Current inspection technologies meet the requirements to properly inspect the existing drug product portfolio, but as new pipeline drugs enter commercial manufacturing, inspection will become a pressing issue from operational efficiency, compliance, and quality standpoints. It is known that the properties of some of these pipeline products render them "uninspectable" by currently installed Automatic Visual Inspection Machines (AVIMs) but the scale and scope of the challenge is not well defined currently. The process and approach outlined in this research focuses on distilling large datasets of future product forecasts together with product attributes and infrastructure capability to generate a quantitative understanding of the future challenge. Through this research, product attributes critical to inspection such as viscosity, presentation, and protein aggregation, are identified for each commercial and pipeline drug product. These attributes are paired with production forecasts to generate attribute focused inspection requirements through 2020, which are then mapped against current capabilities. Gaps identified between requirements and current infrastructure capabilities are determined and the scale quantified. These capability gaps are then segmented by potential solutions, complexity of solutions, and cost of inaction in order to give Amgen the best foresight into future decisions and investments. Based on the gaps identified and near term engineering challenges, several solutions are developed, proposed, and tested throughout the internship. These include the use of Surface Acoustic Waves (SAW) to agitate heavy particles into suspension through acoustic streaming, enhanced lighting and imaging techniques to better identify particles, and segmented machine vision algorithms. These approaches are part of a larger portfolio of technical solutions which must be developed to address future product attributes which render current inspection processes ineffective.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309452058 Total Pages :231 pages Book Rating :4.3/5 (94 download)
Book Synopsis Preparing for Future Products of Biotechnology by : National Academies of Sciences, Engineering, and Medicine
Download or read book Preparing for Future Products of Biotechnology written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-07-28 with total page 231 pages. Available in PDF, EPUB and Kindle. Book excerpt: Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5â€"10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.
Book Synopsis Global Trends 2040 by : National Intelligence Council
Download or read book Global Trends 2040 written by National Intelligence Council and published by Cosimo Reports. This book was released on 2021-03 with total page 158 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The ongoing COVID-19 pandemic marks the most significant, singular global disruption since World War II, with health, economic, political, and security implications that will ripple for years to come." -Global Trends 2040 (2021) Global Trends 2040-A More Contested World (2021), released by the US National Intelligence Council, is the latest report in its series of reports starting in 1997 about megatrends and the world's future. This report, strongly influenced by the COVID-19 pandemic, paints a bleak picture of the future and describes a contested, fragmented and turbulent world. It specifically discusses the four main trends that will shape tomorrow's world: - Demographics-by 2040, 1.4 billion people will be added mostly in Africa and South Asia. - Economics-increased government debt and concentrated economic power will escalate problems for the poor and middleclass. - Climate-a hotter world will increase water, food, and health insecurity. - Technology-the emergence of new technologies could both solve and cause problems for human life. Students of trends, policymakers, entrepreneurs, academics, journalists and anyone eager for a glimpse into the next decades, will find this report, with colored graphs, essential reading.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309495679 Total Pages :393 pages Book Rating :4.3/5 (94 download)
Book Synopsis Safeguarding the Bioeconomy by : National Academies of Sciences, Engineering, and Medicine
Download or read book Safeguarding the Bioeconomy written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-05-01 with total page 393 pages. Available in PDF, EPUB and Kindle. Book excerpt: Research and innovation in the life sciences is driving rapid growth in agriculture, biomedical science, information science and computing, energy, and other sectors of the U.S. economy. This economic activity, conceptually referred to as the bioeconomy, presents many opportunities to create jobs, improve the quality of life, and continue to drive economic growth. While the United States has been a leader in advancements in the biological sciences, other countries are also actively investing in and expanding their capabilities in this area. Maintaining competitiveness in the bioeconomy is key to maintaining the economic health and security of the United States and other nations. Safeguarding the Bioeconomy evaluates preexisting and potential approaches for assessing the value of the bioeconomy and identifies intangible assets not sufficiently captured or that are missing from U.S. assessments. This study considers strategies for safeguarding and sustaining the economic activity driven by research and innovation in the life sciences. It also presents ideas for horizon scanning mechanisms to identify new technologies, markets, and data sources that have the potential to drive future development of the bioeconomy.
Book Synopsis Next Generation Supply Chains by : Rosanna Fornasiero
Download or read book Next Generation Supply Chains written by Rosanna Fornasiero and published by Springer Nature. This book was released on 2020-12-31 with total page 298 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book explores supply chains strategies to help companies face challenges such as societal emergency, digitalization, climate changes and scarcity of resources. The book identifies industrial scenarios for the next decade based on the analysis of trends at social, economic, environmental technological and political level, and examines how they may impact on supply chain processes and how to design next generation supply chains to answer these challenges. By mapping enabling technologies for supply chain innovation, the book proposes a roadmap for the full implementation of the supply chain strategies based on the integration of production and logistics processes. Case studies from process industry, discrete manufacturing, distribution and logistics, as well as ICT providers are provided, and policy recommendations are put forward to support companies in this transformative process.
Book Synopsis Drug Discovery and Drug Development by : Madhu Dikshit
Download or read book Drug Discovery and Drug Development written by Madhu Dikshit and published by Springer. This book was released on 2022-02-11 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Over the years, India has attained a prominent global position in the manufacture of Generic Drugs. This success can be attributed to its synthetic organic chemistry and chemical engineering strengths, nurtured by the timely policies of the Government of India. However, breakthrough successes in New Drug Discovery have remained elusive, despite the brilliant and sustained efforts of many Indian researchers and Pharma establishments. The Indian National Science Academy thought it appropriate to document India’s New Drug Discovery Research (NDDR) journey to date. Gathering contributions from prominent researchers in the Indian Pharma Industry and Academia, this book highlights their efforts, achievements, and the status quo of Indian NDDR.
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 China’s Grand Strategy by : Andrew Scobell
Download or read book China’s Grand Strategy written by Andrew Scobell and published by Rand Corporation. This book was released on 2020-07-27 with total page 155 pages. Available in PDF, EPUB and Kindle. Book excerpt: To explore what extended competition between the United States and China might entail out to 2050, the authors of this report identified and characterized China’s grand strategy, analyzed its component national strategies (diplomacy, economics, science and technology, and military affairs), and assessed how successful China might be at implementing these over the next three decades.
Book Synopsis Artificial Intelligence in Drug Discovery by : Nathan Brown
Download or read book Artificial Intelligence in Drug Discovery written by Nathan Brown and published by Royal Society of Chemistry. This book was released on 2020-11-04 with total page 425 pages. Available in PDF, EPUB and Kindle. Book excerpt: Following significant advances in deep learning and related areas interest in artificial intelligence (AI) has rapidly grown. In particular, the application of AI in drug discovery provides an opportunity to tackle challenges that previously have been difficult to solve, such as predicting properties, designing molecules and optimising synthetic routes. Artificial Intelligence in Drug Discovery aims to introduce the reader to AI and machine learning tools and techniques, and to outline specific challenges including designing new molecular structures, synthesis planning and simulation. Providing a wealth of information from leading experts in the field this book is ideal for students, postgraduates and established researchers in both industry and academia.
Book Synopsis Biotechnology Entrepreneurship by : Craig Shimasaki
Download or read book Biotechnology Entrepreneurship written by Craig Shimasaki and published by Academic Press. This book was released on 2014-04-08 with total page 489 pages. Available in PDF, EPUB and Kindle. Book excerpt: As an authoritative guide to biotechnology enterprise and entrepreneurship, Biotechnology Entrepreneurship and Management supports the international community in training the biotechnology leaders of tomorrow. Outlining fundamental concepts vital to graduate students and practitioners entering the biotech industry in management or in any entrepreneurial capacity, Biotechnology Entrepreneurship and Management provides tested strategies and hard-won lessons from a leading board of educators and practitioners. It provides a ‘how-to’ for individuals training at any level for the biotech industry, from macro to micro. Coverage ranges from the initial challenge of translating a technology idea into a working business case, through securing angel investment, and in managing all aspects of the result: business valuation, business development, partnering, biological manufacturing, FDA approvals and regulatory requirements. An engaging and user-friendly style is complemented by diverse diagrams, graphics and business flow charts with decision trees to support effective management and decision making. Provides tested strategies and lessons in an engaging and user-friendly style supplemented by tailored pedagogy, training tips and overview sidebars Case studies are interspersed throughout each chapter to support key concepts and best practices. Enhanced by use of numerous detailed graphics, tables and flow charts
Book Synopsis Biological Threats and Terrorism by : Institute of Medicine
Download or read book Biological Threats and Terrorism written by Institute of Medicine and published by National Academies Press. This book was released on 2002-03-07 with total page 335 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the wake of September 11th and recent anthrax events, our nation's bioterrorism response capability has become an imminent priority for policymakers, researchers, public health officials, academia, and the private sector. In a three-day workshop, convened by the Institute of Medicine's Forum on Emerging Infections, experts from each of these communities came together to identify, clarify, and prioritize the next steps that need to be taken in order to prepare and strengthen bioterrorism response capabilities. From the discussions, it became clear that of utmost urgency is the need to cast the issue of a response in an appropriate framework in order to attract the attention of Congress and the public in order to garner sufficient and sustainable support for such initiatives. No matter how the issue is cast, numerous workshop participants agreed that there are many gaps in the public health infrastructure and countermeasure capabilities that must be prioritized and addressed in order to assure a rapid and effective response to another bioterrorist attack.
Book Synopsis Artificial Intelligence in Healthcare by : Adam Bohr
Download or read book Artificial Intelligence in Healthcare written by Adam Bohr and published by Academic Press. This book was released on 2020-06-21 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: Artificial Intelligence (AI) in Healthcare is more than a comprehensive introduction to artificial intelligence as a tool in the generation and analysis of healthcare data. The book is split into two sections where the first section describes the current healthcare challenges and the rise of AI in this arena. The ten following chapters are written by specialists in each area, covering the whole healthcare ecosystem. First, the AI applications in drug design and drug development are presented followed by its applications in the field of cancer diagnostics, treatment and medical imaging. Subsequently, the application of AI in medical devices and surgery are covered as well as remote patient monitoring. Finally, the book dives into the topics of security, privacy, information sharing, health insurances and legal aspects of AI in healthcare. - Highlights different data techniques in healthcare data analysis, including machine learning and data mining - Illustrates different applications and challenges across the design, implementation and management of intelligent systems and healthcare data networks - Includes applications and case studies across all areas of AI in healthcare data
Book Synopsis Technology Business Incubation by : Rustam Lalkaka
Download or read book Technology Business Incubation written by Rustam Lalkaka and published by UNESCO. This book was released on 2006-01-01 with total page 144 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many businesses around the world use technology as a means to set-up, run and improve their commercial performance but not all countries have sufficient access to technology. In fact the ’digital divide' between rich and poor countries is one of the major international challenges facing our society. Technology Business Incubation describes a concept whereby technological support and services are offered to start-up companies in the fields of engineering, science and technology to help them further their own research and develop viable businesses. Aimed at developed and developing countries this concept could provide a solution in bridging the knowledge gap. Written by Rustam Lalkaka, a well-known expert in the field, the toolkit provides invaluable information for carrying out feasibility studies; preparing business plans; choosing a location; finding sponsors; selecting managers and tenants; and monitoring a technology business incubator. Annexes contain checklists and report pro formas to help prepare relevant documents based on local needs
Book Synopsis Rare Diseases and Orphan Products by : Institute of Medicine
Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Book Synopsis Single-Use Technology in Biopharmaceutical Manufacture by : Regine Eibl
Download or read book Single-Use Technology in Biopharmaceutical Manufacture written by Regine Eibl and published by John Wiley & Sons. This book was released on 2019-07-18 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: Authoritative guide to the principles, characteristics, engineering aspects, economics, and applications of disposables in the manufacture of biopharmaceuticals The revised and updated second edition of Single-Use Technology in Biopharmaceutical Manufacture offers a comprehensive examination of the most-commonly used disposables in the manufacture of biopharmaceuticals. The authors—noted experts on the topic—provide the essential information on the principles, characteristics, engineering aspects, economics, and applications. This authoritative guide contains the basic knowledge and information about disposable equipment. The author also discusses biopharmaceuticals’ applications through the lens of case studies that clearly illustrate the role of manufacturing, quality assurance, and environmental influences. This updated second edition revises existing information with recent developments that have taken place since the first edition was published. The book also presents the latest advances in the field of single-use technology and explores topics including applying single-use devices for microorganisms, human mesenchymal stem cells, and T-cells. This important book: • Contains an updated and end-to-end view of the development and manufacturing of single-use biologics • Helps in the identification of appropriate disposables and relevant vendors • Offers illustrative case studies that examine manufacturing, quality assurance, and environmental influences • Includes updated coverage on cross-functional/transversal dependencies, significant improvements made by suppliers, and the successful application of the single-use technologies Written for biopharmaceutical manufacturers, process developers, and biological and chemical engineers, Single-Use Technology in Biopharmaceutical Manufacture, 2nd Edition provides the information needed for professionals to come to an easier decision for or against disposable alternatives and to choose the appropriate system.
Author :Advisory Committee on Technology and Society Publisher :National Academies Press ISBN 13 :9780309037860 Total Pages :1298 pages Book Rating :4.0/5 (378 download)
Book Synopsis Cities and Their Vital Systems by : Advisory Committee on Technology and Society
Download or read book Cities and Their Vital Systems written by Advisory Committee on Technology and Society and published by National Academies Press. This book was released on 1989 with total page 1298 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cities and Their Vital Systems asks basic questions about the longevity, utility, and nature of urban infrastructures; analyzes how they grow, interact, and change; and asks how, when, and at what cost they should be replaced. Among the topics discussed are problems arising from increasing air travel and airport congestion; the adequacy of water supplies and waste treatment; the impact of new technologies on construction; urban real estate values; and the field of "telematics," the combination of computers and telecommunications that makes money machines and national newspapers possible.
Download or read book Engineering written by Unesco and published by UNESCO. This book was released on 2010-01-01 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report reviews engineering's importance to human, economic, social and cultural development and in addressing the UN Millennium Development Goals. Engineering tends to be viewed as a national issue, but engineering knowledge, companies, conferences and journals, all demonstrate that it is as international as science. The report reviews the role of engineering in development, and covers issues including poverty reduction, sustainable development, climate change mitigation and adaptation. It presents the various fields of engineering around the world and is intended to identify issues and challenges facing engineering, promote better understanding of engineering and its role, and highlight ways of making engineering more attractive to young people, especially women.--Publisher's description.
