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Focusing on the application of various drying technologies to the processing of pharmaceuticals and biologicals, this is a comprehensive technical overview of novel as well as standard methods, addressing such issues as why drying is required and what needs to be considered when implementing this process during drug product development. The editors are renowned experts from the pharmaceutical industry and have assembled here leaders from industry and academia to share their experiences and offer insights. The authors concentrate on industrial solutions, outlining various drying technologies from an application-oriented point of view and with regard to real-world challenges in the field of drug product development. They describe well established methods, including freeze and spray drying, alongside promising next-generation technologies, possible improvements, limitations, synergies and future directions.Biografía del autor:
Satoshi Ohtake is the Senior Principal Scientist in Pharmaceutical Research & Development, BioTherapeutics Pharmaceutical Sciences at Pfizer in St. Louis (USA). He obtained his B.S. in Chemical Engineering from the California Institute of Technology (USA) and his Ph.D. in Chemical Engineering from the University of Wisconsin (USA). Ohtake has worked for over ten years in several biotechnology and pharmaceutical companies and focused on formulation and technology development of various compounds ranging from small molecules to live attenuated vaccines. He is co-inventor of over 10 patents and patent applications, over 20 articles in peer reviewed journals, and more than 15 invited presentations. Ohtake is a member of the Scientific Advisory Committee for the Journal of Pharmaceutical Sciences. Ken-ichi Izutsu is a Section Chief Research Scientist at the National Institute of Health Sciences (Japan). He received his doctorate degree from Nagoya City University (Japan) in 1994 and worked as visiting scientist at the University of Colorado Health Sciences Center from 1995 to 1997. He is co-author of over 50 articles in peer reviewed journals and member of the Scientific Advisory Committee for the Journal of Pharmaceutical Sciences. Since 2007 Izutsu is External Scientific Advisor of the Pharmaceuticals and Medical Devices Agency (Japan). Izutsu's main research objective is to improve the quality of freeze-dried protein and drug delivery system formulations by controlling physical properties. David Lechuga-Ballesteros is a Principal Scientist at Pearl Therapeutics (USA), working on the development of spray dried inhalation products. He earned his B.S. from the Universidad Nacional Autonoma de Mexico in 1984, and received his Ph.D. in Pharmaceutics from the University of Michigan (USA) in 1993. He has over twenty years of industrial experience, most of them devoted to the development of inhalation products. Prior to Pearl Therapeutics, he worked at Aridis Pharmaceuticals and developed inhaled human monoclonal antibodies and antibiotic formulations for the treatment of cystic fibrosis. At Nektar Therapeutics (USA) he established and directed the pharmaceutical materials sciences function, which enabled the design of dispersible and stable spray dried powders for inhalation. Lechuga-Ballesteros is an active contributor to the field of physical pharmacy, with co-authorship of more than 120 publications and inventorship on more than a dozen patents. Amongst others, he currently serves as a member of the Editorial Advisory Board of the Journal of Pharmaceutical Sciences.
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Buchbeschreibung Buch. Zustand: Neu. Neuware -A comprehensive source of information about modern drying technologies that uniquely focus on the processing of pharmaceuticals and biologicalsDrying technologies are an indispensable production step in the pharmaceutical industry and the knowledge of drying technologies and applications is absolutely essential for current drug product development. This book focuses on the application of various drying technologies to the processing of pharmaceuticals and biologicals. It offers a complete overview of innovative as well as standard drying technologies, and addresses the issues of why drying is required and what the critical considerations are for implementing this process operation during drug product development.Drying Technologies for Biotechnology and Pharmaceutical Applications discusses the state-of-the-art of established drying technologies like freeze- and spray- drying and highlights limitations that need to be overcome to achieve the future state of pharmaceutical manufacturing. The book also describes promising next generation drying technologies, which are currently used in fields outside of pharmaceuticals, and how they can be implemented and adapted for future use in the pharmaceutical industry. In addition, it deals with the generation of synergistic effects (e.g. by applying process analytical technology) and provides an outlook toward future developments.-Presents a full technical overview of well established standard drying methods alongside various other drying technologies, possible improvements, limitations, synergies, and future directions-Outlines different drying technologies from an application-oriented point of view and with consideration of real world challenges in the field of drug product development-Edited by renowned experts from the pharmaceutical industry and assembled by leading experts from industry and academiaDrying Technologies for Biotechnology and Pharmaceutical Applications is an important book for pharma engineers, process engineers, chemical engineers, and others who work in related industries. 380 pp. Englisch. Artikel-Nr. 9783527341122