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Process Validation in Manufacturing of Biopharmaceuticals
The fourth edition of Process Validation in Manufacturing of Biopharmaceuticals is a practical and comprehensive resource illustrating the different approaches for successful validation of biopharmaceutical processes. A pivotal text in its field, this new edition provides guidelines and current practices, contains industrial case studies, and is expanded to include in-depth analysis of the new Process Validation (PV) guidance from the US FDA. Key Features: Offers readers a thorough understanding of the key concepts that form the basis of a good process validation program for biopharmaceuticals. Includes case studies from the various industry leaders that demonstrate application of these conc...
Comprehensive Biotechnology
The second edition of Comprehensive Biotechnology, Six Volume Set continues the tradition of the first inclusive work on this dynamic field with up-to-date and essential entries on the principles and practice of biotechnology. The integration of the latest relevant science and industry practice with fundamental biotechnology concepts is presented with entries from internationally recognized world leaders in their given fields. With two volumes covering basic fundamentals, and four volumes of applications, from environmental biotechnology and safety to medical biotechnology and healthcare, this work serves the needs of newcomers as well as established experts combining the latest relevant sci...
Optical Sensor Systems in Biotechnology
Of all things natural, light is the most sublime. From the very existential belief of the origins of the universe to its role in the evolution of life on earth, light has been inextricably woven into every aspect of our lives. I am grateful to Springer-Verlag and Thomas Scheper for this invitation to organize this volume that continues to expand the use of light to create next generation sensing applications. Indeed, the very act of expanding the frontiers of learning and knowledge are referred to in many languages and cultures as enlightenment. Early optical instruments relied largely on simple combinations of mirrors, prisms and lenses. With these simple devices, substantial progress was m...
Continuous Pharmaceutical Processing and Process Analytical Technology
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...
Third International Conference on Foundations of Computer-aided Process Operations
With an international scope this book compiles the best available knowledge from experts working in more than 21 countries. Combining summaries from a number of sessions from the recent symposium and dealing with the use of computers in support of process operations.
Third World
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