Single-Use Technology in Biopharmaceutical Manufacture 2nd Edition

Book Preface

Single‐use devices have become a major part of the biopharmaceutical production process. They now make up 85% of the equipment in preclinical bioprocessing and are increasingly being employed in the commercial manufacture of biopharmaceuticals. It is in upstream processing, which can be accomplished entirely with single‐use technology, where they are used with greatest diversity, for example, in the manufacturing of modern antibodies and vaccines. Single‐use solutions are also, however, available for downstream processing and for Fill & Finish which are accepted by users. Today, the first fully single‐use production facilities have already become a reality.
It seems that users have more confidence in single‐use technology, which can be explained by the further devel-opment and the improved design of such devices. The new generations of single‐use devices are more robust and easier to handle than their predecessors. Possible problems, such as leakage and integrity, have already been addressed by the suppliers during the manufactur-ing process. Moreover, progress has been made in film technologies, bioreactor design, sensor techniques, and automation.
The second edition of the book Single‐Use Techno­logy in Biopharmaceutical Manufacture consists of an introduction section for beginners and a case‐study collection for advanced‐level readers. It summarizes the latest developments in single‐use technologies. In  addition to a presentation of single‐use systems as applied to different unit operations and to platform technologies, their selection, implementation, and level of trouble‐free usage are discussed. This includes approaches to intensify bioprocesses and to  realize continuous processes but also to aspects of quality assurance and standardization, the influence of single‐use technology on the environment, and the impor-tance of risk analysis.
We would like to thank all authors for their valuable contributions to the new edition of this book. We would also like to extend our special thanks to the management of the Department for Life Sciences and Facility Management of the Zurich University of Applied Sciences for their support in realizing this book. We hope that the new edition of Single‐Use Technology in Biopharmaceutical Manufacture will be helpful for bachelor and master students of biotechnology and related fields, for experienced practitioners who are developing as well as producing biopharmaceuticals and designing production facilities, and, finally, for those who intend to begin using disposables.

Regine and Dieter Eibl