Single-Use Technology in Biopharmaceutical Manufacture

This book gives an overview of commonly-used disposables in the manufacture of biopharmaceuticals, their working principles, characteristics, engineering aspects, economics, and applications. With this information, readers will be able to come to an easier decision for or against disposable alternatives and to choose the appropriate system. The book is divided into two parts – the first is related to basic knowledge about disposable equipment; and the second discusses applications through case studies that illustrate manufacturing, quality assurance, and environmental influence.Content: Chapter 1 Single?Use Equipment in Biopharmaceutical Manufacture: A Brief Introduction (pages 1–11): Dieter Eibl, Thorsten Peuker and Regine EiblChapter 2 Single?Use Bag Systems for Storage, Transportation, Freezing, and Thawing (pages 13–20): Nathalie Riesen and Regine EiblChapter 3 Bag Mixing Systems for Single?Use (pages 21–32): Soren Werner, Matthias Kraume and Dieter EiblChapter 4 Single?Use Bioreactors—An Overview (pages 33–51): Regine Eibl, Christian Loffelholz and Dieter EiblChapter 5 Systems for Coupling and Sampling (pages 53–65): Sebastian Rothe and Dieter EiblChapter 6 Disposable Sensor Systems (pages 67–81): Patrick Lindner, Christian Endres, Arne Bluma, Tim Hopfner, Anne Glindkamp, Claas Haake, Daniel Landgrebe, Daniel Riechers, Richard Baumfalk, Bernd Hitzmann, Thomas Scheper and Kenneth F. ReardonChapter 7 Bioinformatics and Single Use (pages 83–90): Barbara A. Paldus and Mark D. SelkerChapter 8 Single?Use Downstream Equipment (pages 91–103): Alexander Tappe and Uwe GottschalkChapter 9 Single?Use Technology for Formulation and Filling Application (pages 105–112): Jens Kubischik and Michael SchauppChapter 10 Production of Disposable Bags: A Manufacturer's Report (pages 113–134): Steven Vanhamel and Charlotte MasyChapter 11 Disposable Filter Devices (pages 135–143): Thomas Loewe and Mandar DixitChapter 12 Biopharmaceutical Manufacturing Facilities Integrating Single?Use Systems (pages 145–158): Thorsten Peuker and Dieter EiblChapter 13 An Introduction to the Validation and Qualification of Disposables Used in Biomanufacture—A User's Perspective (pages 159–172): Tobias MerseburgerChapter 14 Waste Treatment Options, and the Environmental Impact of Single?Use Systems (pages 173–182): Urs BaierChapter 15 Next?Generation Single?Use Bioreactor Technology and the Future of Biomanufacturing: A Summary from the Manufacturer's and User's Perspective (pages 183–195): Brian Lee, Eric Langer and Ran ZhengChapter 16 Disposable SuperSpinner: Characteristics and Typical Applications (pages 197–205): Andreas Kocourek, Jacqueline Herrmann, Lidija Lisica, Irina Bauer and Regine EiblChapter 17 A New Scale?Down Approach for the Rapid Development of Sf21/BEVS?Based Processes—A Case Study (pages 207–213): Christoph Ries, Corinne John and Regine EiblChapter 18 Practical Aspects of Establishing Pharmaceutical Recombinant Proteins from Research to Development in Disposable Bioreactors (pages 215–223): Joerg Schmidt, Claudia Probst and Cornelia FuxChapter 19 Single?Use Stirred Tank Reactor BIOSTAT CultiBag STR: Characterization and Applications (pages 225–240): Ute Noack, Davy De Wilde, Francis Verhoeye, Edward Balbirnie, Wolfgang Kahlert, Thorsten Adams, Gerhard Greller and Oscar?Werner ReifChapter 20 Single?Use Bioreactor Platform for Microbial Fermentation (pages 241–250): Parrish M. Galliher, Geoff Hodge, Patrick Guertin, Lawrence Chew and Ted DeloggioChapter 21 Growth of BY?2 Suspension Cells and Plantibody Production in Single?Use Bioreactors (pages 251–261): Nicole Raven, Stefan Schillberg, Janina Kirchhoff, Johanna Brandli, Nicole Imseng and Regine EiblChapter 22 CFD as a Tool to Characterize Single?Use Bioreactors (pages 263–279): Christian Loffelholz, Stephan C. Kaiser, Soren Werner and Dieter EiblChapter 23 Automated Disposable Systems: Application Reports (pages 281–294): Nicola Franscini, Iris Poggendorf, Clara Cavelier, Jens M. Kelm, Wolfgang Moritz and Ursula Graf?HausnerChapter 24 New Single?Use Sensors for Online Measurement of Glucose and Lactate: The Answer to the PAT Initiative (pages 295–299): Stefan Spichiger and Ursula E. Spichiger?KellerChapter 25 Disposable Chromatography for Large?Scale Biomanufacturing (pages 301–309): Andre Pastor and Stephan BarbeChapter 26 Single?Use Virus Clearance Technologies in Biopharmaceutical Manufacturing: Case Studies (pages 311–322): Suma Ray and Sherri DolanChapter 27 A Single?Use Technology Platform for Downstream Processing: Mobius FlexReady Solutions (pages 323–331): Gerd WalterChapter 28 The Manufacture of mAbs—A Comparison of Performance and Process Time between Traditional and Ready?to?Use Disposable Systems (pages 333–340): Jakob Liderfelt, Gustav Rodrigo and Annika ForssChapter 29 Going Fully Disposable—Current Possibilities: A Case Study from Crucell (pages 341–349): Alfred Luitjens and Alain PralongChapter 30 Production Costs in Biotech Facilities: Single?Use versus Multiple?Use Equipment for Antibody Manufacture (pages 351–361): Anke Seeger and David Estape