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Stem cell production : Processes, practices and regulations
Examines the technologies and processes for the development and commercial production of stem cells according to cGMP guidelines. The initial chapter of the book discusses the therapeutic potentials of stem cells for the treatment of various diseases, including degenerative disorders and genetic diseases. The book then reviews the recent developments in the cultivation of stem cells in bioreactors, including critical cultural parameters, possible bioreactor configuration and integrations of novel technologies in bioprocess developmental stages. The book also introduces microscopic, molecular, and cellular techniques for characterization of stem cells for regulatory approvals. Further, it describes optimal cell transporting conditions to maintain cell viability and properties. Further, it summarizes characterization strategies of clinical grade stem cells for stem cell therapy. This book is an invaluable contribution to having an academic and industrial understanding with respect to R&D and manufacturing of clinical grade stem cells.
Protein Chromatography : Process Development and Scale-Up
Divided into two large parts, Protein Chromatography: Process Development and Scale-Up, Second Edition presents all the necessary knowledge for effective process development in chromatographic bioseparation, both on small and large scale. The first part introduces chromatographic theory, including process design principles, to enable the reader to rationalize the set-up of a bioseparation process. The second part illustrates by way of case studies and sample protocols how the theory learned in the first part may be applied to real-life problems.
Continuous pharmaceutical processing and process analytical technology
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.
Characterization of Polymer Surfaces and Thin Films
Comprehensive characterization of surfaces and interfaces is essential to relate surface and thin film properties to micro structure and molecular origin, which is, on the other hand, the key to technological control and improvement of materials. This volume cover a representative spectrum of surface sensitive techniques and their application to polymer surface and thin film characterization as well as recent examples of technologically relevant materials and process development.
Agitator Design for Gas-Liquid Fermenters and Bioreactors
Agitator Design for Gas-Liquid Fermenters and Bioreactors delivers a concise treatment and explanation of how to design mechanically sound agitation systems that will perform the agitation process function efficiently and economically. The book covers agitator fundamentals, impeller systems, optimum power and air flow at peak mass transfer calculations, optimizing operation for minimum energy per batch, heat transfer surfaces and calculations, shaft seal considerations, mounting methods, mechanical design, and vendor evaluation.
