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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.

This volume presents the reader with an overview of current chemical sensor technology and outlines a framework relating industrial bioprocess monitoring to modern process control technology. It deals with conventional multivariable control technology, focusing on bioprocess applications.

Using clear language along with numerous case studies, examples, tables, flow charts, and schematics Process Scale Bioseparations for the Biopharmaceutical Industry brings together scientific principles, empirical approaches, and practical considerations for designing industrial downstream bioprocesses for various classes of biomolecules. Experienc

This book is a comprehensive guide to the design and analysis of the most advanced technologies for fuel ethanol production from feedstocks. It describes how process systems engineering can be applied to fuel ethanol production to achieve new levels of efficiency according to technical, economic, and environmental criteria. The authors cover liq

This book addresses the rapidly emerging field of Knowledge Management in the pharmaceutical, medical devices and medical diagnostics industries. In particular, it explores the role that Knowledge Management can play in ensuring the delivery of safe and effective products to patients. The book also provides good practice examples of how the effe

This reference provides an in-depth analysis of bioreactor design and operation, encompassing critical aspects of the biocatalytic manufacturing process. Biotransformation and Bioprocesses clarifies principles in reaction and biochemical engineering, synthetic and biotransformation chemistry, and biocell and enzyme kinetics. It examines cross-linked and designer enzymes, abzymes, and site-selective modification of enzymes for improved stability, specificity, and performance; explores biochemical separations and downstream processing and purification approaches; and illustrates the advantages of chemical waste treatment methods for solids, liquids, and gas.

Contributors from universities and food, pharmaceutical, and brewing companies detail the current state of yeast strain development and handling, highlighting advances in yeast selection for academic research, industry, and recombinant DNA technology. Featuring the use of Saccharomyces and other yea

Fills a gap between the existing studies of proteins, which tend to be highly technical and geared toward the practicing protein chemist, and biochemistry textbooks, which focus on general principles. Scientists cover a dozen topics by presenting fundamental principles, an overview, and the practica

Contributors from European and US universities and corporations review recent developments in the integration of downstream processing and bioconversion, describing their experience with many separation technologies, including some still in the experimental stage. The topics include the construction

Offers coverage of the development of protein purification processes for large-scale commercial operations, and addresses process development, scale-up, applications and mathematical descriptions. Technologies currently used at the commercial scale are covered in depth.

Covers fundamental notions of virology and animal cell cultivation. This practical reference examines the development of insect cell culture techniques for the production of recombinant proteins and insect pathogenic viruses.

Details the recovery, separation, and purification operations of bioprocess technology. This title includes sections on concentration separation and operation, purification operations, and product release and recovery. It also discusses plant operation and equipment and delves into economic considerations.

This book addresses the rapidly emerging field of Knowledge Management in the pharmaceutical, medical devices and medical diagnostics industries. In particular, it explores the role that Knowledge Management can play in ensuring the delivery of safe and effective products to patients. The book also provides good practice examples of how the effective use of an organisationΓÇÖs knowledge assets can provide a path towards business excellence.

Offers coverage of the development of protein purification processes for large-scale commercial operations, and addresses process development, scale-up, applications and mathematical descriptions. This title covers technologies used at the commercial scale.

Bridging the gap between laboratory observations and industrial practices, this work presents information on recombinant micro-organisms and their applications in industry and agriculture. It covers recombinant microbes, bacteria, yeasts and fungi.

Describes the techniques and methods involved in the design, operation, preparation and containment of bioreactor systems, taking into account the interrelated effects of variables associated with both upstream and downstream stages of the design process. This work is intended for biochemical, chemical and bioprocess engineers.

Details the state of yeast strain development and handling, highlighting advances in yeast selection for academic research, industry, and recombinant DNA technology.

Covers a dozen topics by presenting fundamental principles and an overview of protein biotechnology.

This book summarizes the state of the art in process analytical technologies applied to various aspects of biopharmaceutical process development and manufacturing. The text summarizes regulatory perspectives, FDA/EMEA guidelines, and new expectations. In addition, it explores new technology, especially in the area of real-time monitoring for end-point control, as well as new sensor and analytical technologies. It details established and emerging measurement technologies, including future needs, and challenges that require further research. The authors also present successful industrial-scale deployment case studies and strategies from the biopharmaceutical industry and discuss future trends.

Presents a comprehensive overview of cell culture technology. This work covers research, principles and equipment affecting advances in the discovery of genes, host cell selection, cloning and gene amplification, bioreactor design, protein purification, optimization and scale-up, product quality and facility design.

Contributors from European and US universities and corporations review recent developments in the integration of downstream processing and bioconversion, describing their experience with many separation technologies, including some still in the experimental stage. The topics include the construction

Process engineering can potentially provide the means to develop economically viable and environmentally friendly technologies for the production of fuel ethanol. This title offers a guide to the design and analysis of the advanced technologies for fuel ethanol production from feedstocks.

Offers an analysis of bioreactor design and operation and encompasses critical aspects of the biocatalytic manufacturing process. This work clarifies principles in reaction and biochemical engineering and biocell and enzyme kinetics for successful applications of biocatalysis and bioprocess technologies in the chiral drug and vitamin industries.

This volume presents the reader with an overview of current chemical sensor technology and outlines a framework relating industrial bioprocess monitoring to modern process control technology. It deals with conventional multivariable control technology, focusing on bioprocess applications.

Presents scientific principles, empirical approaches, and practical considerations for designing industrial downstream bioprocesses for various classes of biomolecules. This work provides experimental design strategies and guidelines for developing application-specific process scale bioseparations.

Offers an introduction to the fundamental phenomena that govern cell adhesion and describes bioengineering processes that employ cell adhesion, focusing on biochemical and biomedical applications. This book examines industrial issues of cell adhesion - from basic concepts, quantitative experiments, and mathematical models to applications.

Discusses metabolic engineering in plant and mammalian cells, bacteria, and yeasts and assesses metabolic engineering applications in agriculture and environmental systems. This book offers an analysis of complex metabolic pathways and ways of employing recombinant DNA techniques to alter cell behavior, metabolic patterns, and product formation.

Presents an interdisciplinary approach, integrating biochemistry, biology, genetics, and engineering for the effective production of protein pharmaceuticals. This title offers a biological perspective of large-scale animal cell culture. It examines diverse processing strategies and process management.