http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
Single-use technology in biopharmaceutical manufacture
1 online resource (xviii, 369, [2] pages) : illustrations
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 â€" 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.
Front Matter -- Basics. Single-Use Equipment in Biopharmaceutical Manufacture: A Brief Introduction / Dieter Eibl, Thorsten Peuker, Regine Eibl -- Single-Use Bag Systems for Storage, Transportation, Freezing, and Thawing / Nathalie Riesen, Regine Eibl -- Bag Mixing Systems for Single-Use / S̲ren Werner, Matthias Kraume, Dieter Eibl -- Single-Use Bioreactors--An Overview / Regine Eibl, Christian L̲ffelholz, Dieter Eibl -- Systems for Coupling and Sampling / Sebastian Rothe, Dieter Eibl -- Disposable Sensor Systems / Patrick Lindner, Christian Endres, Arne Bluma, Tim H̲pfner, Anne Glindkamp, Claas Haake, Daniel Landgrebe, Daniel Riechers, Richard Baumfalk, Bernd Hitzmann, Thomas Scheper, Kenneth F Reardon -- Bioinformatics and Single Use / Barbara A Paldus, Mark D Selker -- Single-Use Downstream Equipment / Alexander Tappe, Uwe Gottschalk -- Single-Use Technology for Formulation and Filling Application / Jens Kubischik, Michael Schaupp -- Production of Disposable Bags: A Manufacturer's Report / Steven Vanhamel, Charlotte Masy -- Disposable Filter Devices / Thomas Loewe, Mandar Dixit -- Biopharmaceutical Manufacturing Facilities Integrating Single-Use Systems / Thorsten Peuker, Dieter Eibl -- An Introduction to the Validation and Qualification of Disposables Used in Biomanufacture--A User's Perspective / Tobias Merseburger -- Waste Treatment Options, and the Environmental Impact of Single-Use Systems / Urs Baier -- Next-Generation Single-Use Bioreactor Technology and the Future of Biomanufacturing: A Summary from the Manufacturer's and User's Perspective / Brian Lee, Eric Langer, Ran Zheng -- Application Reports and Case Studies. Disposable SuperSpinner: Characteristics and Typical Applications / Andreas Kocourek, Jacqueline Herrmann, Lidija Lisica, Irina Bauer, Regine Eibl -- A New Scale-Down Approach for the Rapid Development of 21/BEVS-Based Processes--A Case Study / Christoph Ries, Corinne John, Regine Eibl -- Practical Aspects of Establishing Pharmaceutical Recombinant Proteins from Research to Development in Disposable Bioreactors / Joerg Schmidt, Claudia Probst, Cornelia Fux -- Single-Use Stirred Tank Reactor BIOSTAT CultiBag STR: Characterization and Applications / Ute Noack, Davy De Wilde, Francis Verhoeye, Edward Balbirnie, Wolfgang Kahlert, Thorsten Adams, Gerhard Greller, Oscar-Werner Reif -- Single-Use Bioreactor Platform for Microbial Fermentation / Parrish M Galliher, Geoff Hodge, Patrick Guertin, Lawrence Chew, Ted Deloggio -- Growth of BY-2 Suspension Cells and Plantibody Production in Single-Use Bioreactors / Nicole Raven, Stefan Schillberg, Janina Kirchhoff, Johanna Br̃ndli, Nicole Imseng, Regine Eibl -- CFD as a Tool to Characterize Single-Use Bioreactors / Christian L̲ffelholz, Stephan C Kaiser, S̲ren Werner, Dieter Eibl -- Automated Disposable Systems: Application Reports / Nicola Franscini, Iris Poggendorf, Clara Cavelier, Jens M Kelm, Wolfgang Moritz, Ursula Graf-Hausner -- New Single-Use Sensors for Online Measurement of Glucose and Lactate: The Answer to the PAT Initiative / Stefan Spichiger, Ursula E Spichiger-Keller -- Disposable Chromatography for Large-Scale Biomanufacturing / Andř Pastor, Sťphan Barbe -- Single-Use Virus Clearance Technologies in Biopharmaceutical Manufacturing: Case Studies / Suma Ray, Sherri Dolan -- A Single-Use Technology Platform for Downstream Processing: Mobius FlexReady Solutions / Gerd Walter -- The Manufacture of mAbs--A Comparison of Performance and Process Time between Traditional and Ready-to-Use Disposable Systems / Jakob Liderfelt, Gustav Rodrigo, Annika Forss -- Going Fully Disposable--Current Possibilities: A Case Study from Crucell / Alfred Luitjens, Alain Pralong -- Production Costs in Biotech Facilities: Single-Use versus Multiple-Use Equipment for Antibody Manufacture / Anke Seeger, David Estap̌ -- Index.
Includes bibliographical references and index.