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.