 Single-Use Technology in Biopharmaceutical Manufacture, Regine Eibl and Dieter Eibl, Eds., Wiley, Hoboken, NJ, 2011, 369
pp., ISBN: 9780470433515
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The increasing demand on drug manufacturers to produce efficiently, reduce drug costs, and reduce time to market are several
key reasons for the implementation of single-use systems. Single-Use Technology in Biopharmaceutical Manufacturing provides the reader with background information about this technology, and also describes advances in single-use products.
The book helps guide the reader through the complex decision making process required for implementing disposable components.
The book's editors, Regine and Dieter Eibl, assembled an exceptionally diverse group of academic and industry experts to describe
this increasingly popular technology. The text presents a solid technical and practical review of current single-use products
and their applications in biopharmaceutical manufacturing. The preface defines the book's audience as individuals in advanced
graduate studies in biopharmaceuticals, experienced end-users developing single-use systems, and professionals exploring disposable
options in new or established process systems.
The book is divided into two major sections. The first section is devoted to current single-use products and offers expansive
descriptions of technologies, including mixing and storage containers, complex bioreactor systems, and all the connecting
disposable devices between. The second section delves into the components' practical applications using a case-study approach.
Several of this section's chapters focus on comparable multiuse (i.e., stainless steel) systems and their associated costs.
The chapters are well written and, for the most part, easily readable for technical scientists and staff who do not have an
engineering background. Although the discussion of each topic is brief, the authors present a reasonable amount of detail,
thus giving the reader a comprehensive overview of each single-use technology or application. Each chapter provides a wealth
of references for the reader interested in deep research into these topics.
The book's first section contains well-rounded discussions of disposable components, such as bags, sensors, filtration and
separation devices, downstream processing equipment, connectors, fittings, tubing, and bioreactors. Each chapter details the
core technology and describes the advantages and drawbacks one must consider in implementing single-use products.
The section's contributors are subject-matter experts who explain each product's scope. The authors also list various device
manufacturers for each item and provide basic comparison tables to assist the reader in making informed choices. These tools
should help the reader sort through the myriad of products to select and specify the appropriate system design for his or
her application (e.g., upstream or downstream processing).