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A comprehensive source of information about modern drying technologies that uniquely focus on the processing of pharmaceuticals and biologicals Drying 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 dr...
With the recent completion of the sequencing of the human genome, it is widely anticipated that the number of potential new protein drugs and targets will escalate at an even greater rate than that observed in recent years. However, identification of a potential target is only part of the process in developing these new next generation protein-based “drugs” that are increasingly being used to treat human disease. Once a potential protein drug has been identified, the next rate-limiting step on the road to development is the production of sufficient authentic material for testing, charact- ization, clinical trials, and so on. If a protein drug does actually make it through this lengthy an...
This book comprehensively describes biological phenomena, adaptation mechanisms, and strategies of living organisms to survive under extremely cold or desiccated conditions at molecular, cellular, and organ levels. It also provides tremendous potential for applications of the findings to a wide variety of industries. The volume consists of three parts: Part 1, Adaptation Mechanisms of Cold, and Part 2, Adaptation Mechanisms of Desiccation, collect up-to-date research on mechanisms and strategies of living organisms such as sleeping chironomids, polar marine fishes, hibernating mammals, bryophytes, dormant seeds, and boreal plants to survive under extreme cold and desiccated conditions at mol...
During the past decade, the importance of amorphous water-soluble substances has been increasingly recognised within the food and pharmaceutical industries. In response, Amorphous Food and Pharmaceutical Systems brings together current leading experts to contribute to this unique cross-disciplinary account of the subject. Coverage includes: water-compatible amorphous solids (physical, chemical behaviour), low water content systems (water as plasticizer); applications in food and pharmaceutical sciences and industries (processing and stability) along with state-of-the-art technology in food and pharmaceutical systems. This timely publication will be welcomed by academic and industrial researchers and professionals in the pharmaceuticals, food, materials and polymer sciences.
Continuous manufacturing of pharmaceuticals, including aspects of modern process development is highlighted in this book with both the ‘why’ and the ‘how’, emphasizing process modeling and process analytical technologies. Presenting specific case studies and drawing upon extensive experience from industry and academic opinion leaders, this book focuses on the practical aspects of continuous manufacturing. It gives the readers the strategic perspective and technical depth needed to adopt and implement these technologies, where appropriate, in order to gain the competitive edge in speed, agility, and reliability. Features: Discusses scientific solutions and process analytical technolog...
Thoroughly acquainting the reader with freeze-drying fundamentals, Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Second Edition carves practical guidelines from the very latest theoretical research, technologies, and industrial procedures. It delineates the best execution of steps from closure preparation and regulatory control of products to equipment sterilization and process validation. With 13 new chapters providing state-of-the-art information, the book unveils innovations currently advancing the field, including LYOGUARD® packaging for bulk freeze-drying and the irradiation of pharmaceutical and biological products.
This volume on grammaticalization focuses on new theoretical and methodological challenges underpinning language change. It provides new approaches and insights deepening our understanding of the cognitive, pragmatic, and socio-cultural mechanisms that trigger the formation and the change of grammars. In this volume, grammaticalization is dealt with diachronically, synchronically and as a by-product of dialogic interaction. Another key feature of this book is language diversity; as it includes studies on language families ranging from Niger-Congo, Koreanic, Japonic, Sino-Tibetan to Germanic and Romance. The novel aspects of grammaticalization addressed are new slants on the fundamental debate about grammaticalization as expansion vs reduction; the grammatical formation of ideophones; the semantic domain of fear as a source and a trigger of grammatical change, and many other aspects of semantic and morphosyntactic development.
Freeze-drying, or lyophilization, is a well established technology used in the preservation of numerous pharmaceutical and biological products. This highly effective dehydration method involves the removal of water from frozen materials via the direct sublimation of ice. In recent years, this process has met with many changes, as have the regulatio
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