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 concepts. Discusses the use of modern tools such as multivariate analysis for facilitating a process validation exercise. Covers process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration, and practical methods to test raw materials and in-process samples. Providing a thorough understanding of the key concepts that form the basis of a good process validation program, this book will help readers ensure that PV is carried out and exceeds expectations. Fully illustrated, this is a much-needed practical guide for biopharmaceutical manufacturers.

Authoritative guide to the principles, characteristics, engineering aspects, economics, and applications of disposables in the manufacture of biopharmaceuticals The revised and updated second edition of Single-Use Technology in Biopharmaceutical Manufacture offers a comprehensive examination of the most-commonly used disposables in the manufacture of biopharmaceuticals. The authors—noted experts on the topic—provide the essential information on the principles, characteristics, engineering aspects, economics, and applications. This authoritative guide contains the basic knowledge and information about disposable equipment. The author also discusses biopharmaceuticals’ applications through the lens of case studies that clearly illustrate the role of manufacturing, quality assurance, and environmental influences. This updated second edition revises existing information with recent developments that have taken place since the first edition was published. The book also presents the latest advances in the field of single-use technology and explores topics including applying single-use devices for microorganisms, human mesenchymal stem cells, and T-cells. This important book: • Contains an updated and end-to-end view of the development and manufacturing of single-use biologics • Helps in the identification of appropriate disposables and relevant vendors • Offers illustrative case studies that examine manufacturing, quality assurance, and environmental influences • Includes updated coverage on cross-functional/transversal dependencies, significant improvements made by suppliers, and the successful application of the single-use technologies Written for biopharmaceutical manufacturers, process developers, and biological and chemical engineers, Single-Use Technology in Biopharmaceutical Manufacture, 2nd Edition provides the information needed for professionals to come to an easier decision for or against disposable alternatives and to choose the appropriate system.

In the past few decades, cepezed has gained renown with transparent, sustainable and technologically progressive architecture that is remarkably usable and humane. Unaffected design, sober but stylish materialization, and careful finishing are just as characteristic of Cepezed's oeuvre as the integration of spatial and construction-technical aspects. The design and building processes at cepezed are also integrated: the use of prefab components and the application of industrial building methods guarantee an optimum alignment of design and realization, in which time, quality, and costs are meticulously planned and controlled. Prototypes documents a large number of key projects and deals extensively with the various aspects of product development, building process and architecture. The layout and form of the book make it very similar to a cepezed design: celar, logical and efficient. It offers very incisive insight into the office philosophy that cepezed has drawn straight through architectural history. In addition to the timeless aesthetic pleasure that can be experienced in the designs and the craftmanship displayed at detail level, the much-discussed role of the architect in the design process today is examined in the book. A must read for every architect who wrestles with the threatened depreciation of the discipline.

Sixteenth-century Europe was powered by commerce. Whilst mercantile groups from many areas prospered, those from the Low Countries were particularly successful. This study, based on extensive archival research, charts the ascent of the merchants established around Antwerp.

This volume constitutes the proceedings of the Fourth International Workshop on Materials Processing at High Gravity, held at Clarkson University, May 29 to June 2, 2000. There were 73 attendees from 16 countries. Since the topics extended well beyond materials processing, it was felt appropriate to name this proceedings "Centrifugal Processing." Processing by Centrifugation includes the traditional bench-scale centrifuges, as well as all rotating systems utilizing the centrifugal and Coriolis forces to provide unique performance. Centrifugation led to the formation of sticky porous Teflon membranes, as well as improved polymeric solar cells. Centrifugation on large equipment improved the chemical vapor deposition of diamond films, influenced the growth and dissolution of semiconductor crystals, and elucidated the influence of gravity on coagulation of colloidal Teflon. A million g centrifuge was constructed and used to study sedimentation in solids and to prepare compositionally graded materials and new phases. Rotation of a pipe about its axis allowed the casting of large-diameter metal alloy pipes as well as coating the interior of pipes with a cermet utilizing self-propagating high-temperature synthesis. Such coatings are highly corrosion and erosion resistant. Flow on a rotating disk was shown to be useful for process intensification, such as large-scale manufacturing of nano-particles, polymerization reactions, and heat & mass transfer. Several theoretical studies dealt with the influence of rotation on fluid convection on surfaces and in pipes, tubes, and porous media. These have applications to integrated-circuit chip manufacturing, alloy casting, oil production, crystal growth, and the operation of rotating machinery.

This volume investigates the use of mortgages in the European countryside between the thirteenth and eighteenth centuries. A mortgage allowed a loan to be secured with land or other property, and the practice has been linked to the transformation of the agrarian economy that paved the way for modern economic growth. Historians have viewed the mortgage both positively and negatively: on the one hand, it provided borrowers with opportunities for investment in agriculture; but equally, it exposed them to the risk of losing their mortgaged property. The case studies presented in this volume reveal the variety of forms that the mortgage took, and show how an intricate balance was struck between the interests of the borrower looking for funds, and those of the lender looking for security. It is argued that the character of mortgage law, and the nature of rights in land in operation in any given the place and period, determined the degree to which mortgages were employed. Over time, developments in these factors allowed increasing numbers of peasants to use mortgages more freely, and with a decreasing risk of expropriation. This volume will be appealing to academics and researchers interested in financial history, rural credit and debt, and the economic history of agrarian communities.