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Continuous Manufacturing of Pharmaceuticals (Advances in Pharmaceutical Technology) de Peter Kleinebudde
Descripción - Reseña del editor A comprehensive look at existing technologies and processes for continuous manufacturing of pharmaceuticals As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and raw material use; the accelerated introduction of new drugs; the use of smaller production facilities with lower building and capital costs; the ability to monitor drug quality on a continuous basis; and enhanced process reliability and flexibility. Continuous Manufacturing of Pharmaceuticals prepares professionals to take advantage of that exciting new approach to improving drug manufacturing efficiency. This book covers key aspects of the continuous manufacturing of pharmaceuticals. The first part provides an overview of key chemical engineering principles and the current regulatory environment. The second covers existing technologies for manufacturing both small-molecule-based products and protein/peptide products. The following section is devoted to process analytical tools for continuously operating manufacturing environments. The final two sections treat the integration of several individual parts of processing into fully operating continuous process systems and summarize state-of-art approaches for innovative new manufacturing principles. * Brings together the essential know-how for anyone working in drug manufacturing, as well as chemical, food, and pharmaceutical scientists working on continuous processing * Covers chemical engineering principles, regulatory aspects, primary and secondary manufacturing, process analytical technology and quality-by-design * Contains contributions from researchers in leading pharmaceutical companies, the FDA, and academic institutions * Offers an extremely well-informed look at the most promising future approaches to continuous manufacturing of innovative pharmaceutical products Timely, comprehensive, and authoritative, Continuous Manufacturing of Pharmaceuticals is an important professional resource for researchers in industry and academe working in the fields of pharmaceuticals development and manufacturing. Contraportada A comprehensive look at existing technologies and processes for continuous manufacturing of pharmaceuticals As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and raw material use; the accelerated introduction of new drugs; the use of smaller production facilities with lower building and capital costs; the ability to monitor drug quality on a continuous basis; and enhanced process reliability and flexibility. Continuous Manufacturing of Pharmaceuticals prepares professionals to take advantage of that exciting new approach to improving drug manufacturing efficiency. This book covers key aspects of the continuous manufacturing of pharmaceuticals. The first part provides an overview of key chemical engineering principles and the current regulatory environment. The second covers existing technologies for manufacturing both small-molecule-based products and protein/peptide products. The following section is devoted to process analytical tools for continuously operating manufacturing environments. The final two sections treat the integration of several individual parts of processing into fully operating continuous process systems and summarize state-of-art approaches for innovative new manufacturing principles. Brings together the essential know-how for anyone working in drug manufacturing, as well as chemical, food, and pharmaceutical scientists working on continuous processing Covers chemical engineering principles, regulatory aspects, primary and secondary manufacturing, process analytical technology and quality-by-design Contains contributions from researchers in leading pharmaceutical companies, the FDA, and academic institutions Offers an extremely well-informed look at the most promising future approaches to continuous manufacturing of innovative pharmaceutical products Timely, comprehensive, and authoritative, Continuous Manufacturing of Pharmaceuticals is an important professional resource for researchers in industry and academe working in the fields of pharmaceuticals development and manufacturing. Biografía del autor Peter Kleinebudde, PhD, is Professor for Pharmaceutical Technology at Heinrich-Heine-University Duesseldorf, Germany, and Vice-Dean of the Faculty of Mathematics and Natural Sciences. His main research area is development, production and characterization of solid dosage forms. Johannes Khinast, PhD, is Professor of Chemical and Pharmaceutical Engineering and Head of the Institute of Process and Particle Engineering at the Graz University of Technology, Austria. Jukka Rantanen, PhD, is Professor of Pharmaceutical Technology and Engineering at the Department of Pharmacy, University of Copenhagen, Denmark.
Detalles del Libro
- Name: Continuous Manufacturing of Pharmaceuticals (Advances in Pharmaceutical Technology)
- Autor: Peter Kleinebudde
- Categoria: Libros,Ciencias, tecnología y medicina,Tecnología e ingeniería
- Tamaño del archivo: 8 MB
- Tipos de archivo: PDF Document
- Descargada: 125 times
- Idioma: Español
- Archivos de estado: AVAILABLE
Descargar Continuous Manufacturing of Pharmaceuticals (Advances in Pharmaceutical Technology) de Peter Kleinebudde libros ebooks
Continuous Manufacturing of Pharmaceuticals / Wiley ~ A comprehensive look at existing technologies and processes for continuous manufacturing of pharmaceuticals As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy .
Continuous Manufacturing of Pharmaceuticals / Wiley Online ~ A comprehensive look at existing technologies and processes for continuous manufacturing of pharmaceuticals. As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes.
Continuous Manufacturing of Pharmaceuticals (Advances in ~ Continuous Manufacturing of Pharmaceuticals (Advances in Pharmaceutical Technology) - Kindle edition by Kleinebudde, Peter, Khinast, Johannes, Rantanen, Jukka. Download it once and read it on your Kindle device, PC, phones or tablets. Use features like bookmarks, note taking and highlighting while reading Continuous Manufacturing of Pharmaceuticals (Advances in Pharmaceutical Technology).
Continuous manufacturing of pharmaceuticals (eBook, 2017 ~ Get this from a library! Continuous manufacturing of pharmaceuticals. [Peter Kleinebudde; Johannes Khinast; Jukka Rantanen;] -- "A comprehensive look at existing technologies and processes for continuous manufacturing of pharmaceuticals As rising costs outpace new drug development, the pharmaceutical industry has come under .
Advances in the Pharmaceutical Sciences / Pharmaceutical ~ PTSM: Pharmaceutical Technology Sourcing and Management Volume 5, Issue 7 The pharmaceutical sciences represent an evolving and highly dynamic field, and two overreaching trends show an increased effort to develop biologic-based drugs and creating more specific or targeted drug delivery techniques.
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Continuous Manufacturing: A Generic Industry Perspective ~ 5. FDA “Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base Guidance for Industry” Draft Guidance, December 2015. 6. G. Allison et al., International Symposium on Continuous Manufacturing of Pharmaceuticals: Implementation, Technology & Regulatory (Cambridge, MA, 2014). 7. G.
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CONTINUUS Pharmaceuticals / Home ~ Technology . Rather than producing medicines through batch-wise, step-by-step processes, CONTINUUS Pharmaceuticals offers a breakthrough Integrated Continuous Manufacturing (ICM) technology for small molecule pharmaceuticals. The synthesis of the active ingredient and the final dosage form are integrated into a seamless process.
Continuous Manufacturing in Pharmaceuticals: Implications ~ Continuous manufacturing’s advantages of speed, cost savings, and improved quality are attractive to pharmaceutical manufacturers. The drive to incorporate digitization or attune processes to Industry 4.0 is another factor driving the trend towards continuous manufacturing, as it is highly compatible with automation.
Continuous Manufacturing of Pharmaceuticals - ISBN ~ Continuous Manufacturing of Pharmaceuticals - ISBN: 9781119001331 - (ebook) - von Peter . Advances in Pharmaceutical Technology 1. Aufl . and PAT 24 1.3.7 Scale-Up 26 1.3.8 Dimensioning 27 1.4 Conclusion 28 References 30 2 Process Simulation and Control for Continuous Pharmaceutical Manufacturing of Solid Drug Products 33Marianthi .
Continuous Processing in Pharmaceutical Manufacturing ~ Continuous Processing in Pharmaceutical Manufacturing. Editor(s): Ganapathy Subramanian; . with a strong focus on continuous processes. Recent advances in single-use technology as well as application guidelines for all types of biopharmaceutical products, from . and pharmaceuticals.
Modernizing Pharmaceutical Manufacturing Continuous ~ Modernizing Pharmaceutical Manufacturing – Continuous Manufacturing as a Key Enabler MIT-CMAC International Symposium on Continuous Manufacturing of Pharmaceuticals Cambridge, MA May 20, 2014 Janet Woodcock, M.D. Center for Drug Evaluation and Research, FDA
Continuous Manufacturing Progress and the Bio ~ In some cases, manufacturing that takes a month by batch technology might only take a day using continuous manufacturing techniques.” 1 And the article ends with; “FDA will continue our efforts to encourage the advancement of continuous manufacturing as one of a variety of ways to enhance the quality of the medications used by the American public.” 1
(PDF) Continuous Process in Pharmaceutical Manufacturing ~ Continuous Process in Pharmaceutical Manufacturing: Considerations, Nuances and Challenges Article (PDF Available) · June 2015 with 4,244 Reads How we measure 'reads'
Continuous Manufacturing And Its Regulatory Challenge ~ In 2019, the FDA issued a new draft guidance entitled “Quality Considerations for Continuous Manufacturing,” which provides FDA’s current thinking on quality considerations for CM of small molecules, solid oral drug products that are regulated by CDER. 9 In this draft guidance, the FDA “focuses on scientific and regulatory considerations that are specific or unique to continuous .
MSc Advanced Pharmaceutical Manufacturing Masters ~ Process Analytical Technology & Quality by Design in Continuous Pharmaceutical Manufacturing This class will also provide insight into the key principles of QbD covering quality risk management, formal experimental design and PAT, including topics such as: PAT tools and Implementation; PAT in Development and Manufacturing; Design of Experiments and Multivariate Data Analysis; Quality by Design .
Pharmaceutical Manufacturing: Current Trends and What’s ~ Various scientific advances are fueling a fresh wave of pharmaceutical manufacturing innovation. These advances are supported by the U.S. Food and Drug Administration (FDA), which is helping accelerate the industry’s throughput of lifesaving medicines and therapeutics by taking a more pragmatic approach to regulation (1).
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The Advent of Continuous Manufacturing / Pharmaceutical ~ Spurred by pressure from governments and consumers to curb rising drug prices, pharmaceutical manufacturers are increasingly willing to look beyond traditional batch processing to cut costs and increase efficiency. One of the industry's most dramatic innovations on this front is continuous manufacturing (CM). The technology, which produces drugs in an uninterrupted process, benefits patients .
Progress Towards Advanced Pharmaceutical Manufacturing ~ Continuous Manufacturing is Now a Global Initiative. While much of the advanced pharmaceutical manufacturing endeavors taking hold today, PAT, QbD, and continuous manufacturing, were spearheaded by the FDA and U.S. based research efforts; the pharmaceutical industry along with most of the organizations at the technological forefront are global.
Regulatory Progress - Global Advancement of Continuous ~ Continuous manufacturing (CM) is an advancement in pharmaceutical manufacturing technology that provides high assurance of product quality as well as enough flexibility and agility in production to respond to market demands. The decision to invest in CM can be challenging for a company given the cost of purchasing the continuous equipment, the resources and expertise required for additional in .
8 Trends in Pharmaceutical Manufacturing to Watch in 2020 ~ Continuous Manufacturing . Continuous manufacturing is continuing to grow as an alternative to batch production. Continuous manufacturing speeds production, reduces the likelihood of human error, and can reduce the need for multiple facilities. While still an emerging technology, the continuous manufacturing market is expanding at a rate of 13% .
True Continuous Manufacturing - Pharmaceutical Manufacturing ~ In the pharmaceutical industry, some manufacturers employ highly automated batch processing in lieu of continuous manufacturing considering it as a superior option. In such instances, there continues to be multiple batch operations such as fluid bed drying linked via automatic transfer systems with these unit operations still needing individual control and monitoring at each stage (Figure 2).