Continuous Manufacturing of Pharmaceuticals

Author: Peter Kleinebudde
Publisher: John Wiley & Sons
ISBN: 1119001331
Format: PDF, Mobi
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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.

Der gleichl ufige Doppelschneckenextruder

Author: Klemens Kohlgrüber
Publisher: Carl Hanser Verlag GmbH Co KG
ISBN: 3446452354
Format: PDF, Kindle
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Alles zum gleichläufigen Doppelschneckenextruder Bei der Herstellung von Kunststoffen, insbesondere bei der Aufbereitung und Verarbeitung bis zum Fertigprodukt werden Extruder eingesetzt, wobei der gleichläufige Doppelschneckenextruder eine dominante Rolle spielt. Aber auch in anderen Industriezweigen, z. B. der Kautschuk- und Lebensmittelindustrie und zunehmend in der Pharmaindustrie kommen die Gleichdrallschnecken vielfältig zum Einsatz. Eine multifunktionale Maschine Das Fachbuch gibt umfassenden Einblick in die verfahrens- und maschinentechnischen Grundlagen und legt großen Fokus auf Praxisbeispiele. Meist sind die Schnecken modular aufgebaut und können damit sehr flexibel an veränderte Aufgabenstellung und Produkteigenschaften angepasst werden. Für die optimale Auslegung eines Doppelschneckenextruders sind vertiefte Kenntnisse über die Maschine und den Prozess erforderlich. Ein Praxisbuch für Einsteiger und Profis Die zweite Auflage entstand unter Mitwirkung vieler Fachautoren von renommierten Firmen und Hochschulen. Alle inzwischen erfolgten Weiterentwicklungen wurden berücksichtigt. Die zweite Auflage wurde durchgehend neu bearbeitet, ist deutlich erweitert, komplett in Farbe und in neuem Layout. Mit Zusatzmaterial auf der Website des Herausgebers: Videos, Bilder, Beispiel-Aufgaben, Rechentools EXTRA: E-Book inside

Continuous Manufacturing for the Modernization of Pharmaceutical Production

Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309487811
Format: PDF, ePub
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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.

Continuous Processing in Pharmaceutical Manufacturing

Author: Ganapathy Subramanian
Publisher: John Wiley & Sons
ISBN: 3527335951
Format: PDF, Kindle
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With contributions from biotechnologists and bioengineers, this ready reference describes the state of the art in industrial biopharmaceutical production, 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 vaccines to antibodies, and from bacterial to insect to mammalian cells are covered. The efficiency, robustness, and quality control of continuous production processes for biopharmaceuticals are reviewed and compared to traditional batch processes for a range of different production systems.

Pharmaceutical Extrusion Technology

Author: Isaac Ghebre-Selassie
Publisher: CRC Press
ISBN: 0824755200
Format: PDF
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Pharmaceutical Extrusion Technology is the only resource to provide in-depth descriptions and analyses of the key parameters of extruders and extrusion processes. The book highlights the applicability of melt extrusion in pharmaceutical drug development and product manufacturing, including controlled release, dissolution rate and bioavailability enhancement, and granulation technology. It brings together the technical information necessary to develop and market pharmaceutical dosage forms that meet current quality and regulatory requirements and details extruder hardware and controls, process definition and troubleshooting of single and twin screw extrusion processes, and more.

Pharmaceutical Extrusion Technology Second Edition

Author: Isaac Ghebre-Sellassie
Publisher: CRC Press
ISBN: 1351129007
Format: PDF, Docs
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The first edition of Pharmaceutical Extrusion Technology, published in 2003, was deemed the seminal book on pharmaceutical extrusion. Now it is expanded and improved, just like the usage of extrusion has expanded, improved and evolved into an accepted manufacturing technology to continuously mix active pharmaceutical ingredients with excipients for a myriad of traditional and novel dosage forms. Pharmaceutical Extrusion Technology, Second Edition reflects how this has spawned numerous research activities, in addition to hardware and process advancements. It offers new authors, expanded chapters and contains all the extrusion related technical information necessary for the development, manufacturing, and marketing of pharmaceutical dosage forms.

Melt Extrusion

Author: Michael A. Repka
Publisher: Springer Science & Business Media
ISBN: 1461484324
Format: PDF, Mobi
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This volume provides readers with the basic principles and fundamentals of extrusion technology and a detailed description of the practical applications of a variety of extrusion processes, including various pharma grade extruders. In addition, the downstream production of films, pellets and tablets, for example, for oral and other delivery routes, are presented and discussed utilizing melt extrusion. This book is the first of its kind that discusses extensively the well-developed science of extrusion technology as applied to pharmaceutical drug product development and manufacturing. By covering a wide range of relevant topics, the text brings together all technical information necessary to develop and market pharmaceutical dosage forms that meet current quality and regulatory requirements. As extrusion technology continues to be refined further, usage of extruder systems and the array of applications will continue to expand, but the core technologies will remain the same.

3D and 4D Printing in Biomedical Applications

Author: Mohammed Maniruzzaman
Publisher: Wiley-VCH
ISBN: 3527344438
Format: PDF, ePub, Mobi
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Ein professioneller Leitfaden zu 3D- und 4D-Drucktechniken in der Biomedizin und Pharmazie. 3D and 4D Printing in Biomedical Applications führt fundiert in 3D- und 4D-Drucktechniken in der Biomedizin und Pharmazie ein. Dieses Fachbuch enthält Beiträge von internationalen Wissenschaftlern und Industrieexperten und bietet einen Überblick über das Thema, aktuelle Forschungsergebnisse und Innovationen zu Anwendungen in der Pharmazie und Biomedizin. Untersucht werden Prozessoptimierung, Innovationsprozesse, Engineering- und Plattformtechnologien. Darüber hinaus informiert das Werk über Entwicklungen in der Biomedizin, u. a. über Formgedächtnispolymere, Biofabrikation in 4D und Knochen aus dem Drucker. Eine Fülle von Themen werden behandelt und näher beleuchtet: Potenzial des 3D-Drucks für die Wirkstoffverabreichung, neue Fertigungsprozess, Bio-Scaffolding, neueste Trends und Herausforderungen für 3D- und 4D-Bioprinting in der Biofabrikation. Dieses wertvolle Referenzwerk - ist ein umfassender Leitfaden zu 3D- und 4D-Drucktechniken in der Biomedizin und Pharmazie. - informiert u. a. über die erste 3D-Druckplattform mit FDA-Zulassung für ein pharmazeutisches Erzeugnis. - enthält Reviews der derzeit verfügbaren pharmazeutischen Erzeugnisse, die per 3D-Druck hergestellt wurden. - präsentiert die jüngsten Fortschritte bei neuartigen Materialien für den 3D- und 4D-Druck und biomedizinische Anwendungen.

Pharmaceutical Extrusion Technology Second Edition

Author: Isaac Ghebre-Sellassie
Publisher: Drugs and the Pharmaceutical Sciences
ISBN: 9781498704915
Format: PDF, Docs
Download Now
The first edition of Pharmaceutical Extrusion Technology , published in 2003, was deemed the seminal book on pharmaceutical extrusion. Now it is expanded and improved, just like the usage of extrusion has expanded, improved and evolved into an accepted manufacturing technology to continuously mix active pharmaceutical ingredients with excipients for a myriad of traditional and novel dosage forms. Pharmaceutical Extrusion Technology, Second Edition reflects how this has spawned numerous research activities, in addition to hardware and process advancements. It offers new authors, expanded chapters and contains all the extrusion related technical information necessary for the development, manufacturing, and marketing of pharmaceutical dosage forms.