Single-Use Technology in Biopharmaceutical Manufacture

Copyright © 2011 John Wiley & Sons, Inc. All rights reserved.

Single-Use Technology in Biopharmaceutical Manufacture

Editor(s): Regine Eibl, Dieter Eibl

Published Online: 19 JAN 2011 12:08PM EST

Print ISBN: 9780470433515

Online ISBN: 9780470909997

DOI: 10.1002/9780470909997

About this Book

Product Information

About The Product

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.

Table of contents

    1. You have free access to this content
      Front Matter (pages i–xviii)

  2. Part I: Basics

    1. Chapter 1

      Single-Use Equipment in Biopharmaceutical Manufacture: A Brief Introduction (pages 1–11)

      Dieter Eibl, Thorsten Peuker and Regine Eibl

    2. Chapter 2

      Single-Use Bag Systems for Storage, Transportation, Freezing, and Thawing (pages 13–20)

      Nathalie Riesen and Regine Eibl

    3. Chapter 3

      Bag Mixing Systems for Single-Use (pages 21–32)

      Sören Werner, Matthias Kraume and Dieter Eibl

    4. Chapter 4

      Single-Use Bioreactors—An Overview (pages 33–51)

      Regine Eibl, Christian Löffelholz and Dieter Eibl

    5. Chapter 5

      Systems for Coupling and Sampling (pages 53–65)

      Sebastian Rothe and Dieter Eibl

    6. Chapter 6

      Disposable Sensor Systems (pages 67–81)

      Patrick Lindner, Christian Endres, Arne Bluma, Tim Höpfner, Anne Glindkamp, Claas Haake, Daniel Landgrebe, Daniel Riechers, Richard Baumfalk, Bernd Hitzmann, Thomas Scheper and Kenneth F. Reardon

    7. Chapter 7

      Bioinformatics and Single Use (pages 83–90)

      Barbara A. Paldus and Mark D. Selker

    8. Chapter 8

      Single-Use Downstream Equipment (pages 91–103)

      Alexander Tappe and Uwe Gottschalk

    9. Chapter 9

      Single-Use Technology for Formulation and Filling Application (pages 105–112)

      Jens Kubischik and Michael Schaupp

    10. Chapter 10

      Production of Disposable Bags: A Manufacturer's Report (pages 113–134)

      Steven Vanhamel and Charlotte Masy

    11. Chapter 11

      Disposable Filter Devices (pages 135–143)

      Thomas Loewe and Mandar Dixit

    12. Chapter 12

      Biopharmaceutical Manufacturing Facilities Integrating Single-Use Systems (pages 145–158)

      Thorsten Peuker and Dieter Eibl

    13. Chapter 13

      An Introduction to the Validation and Qualification of Disposables Used in Biomanufacture—A User's Perspective (pages 159–172)

      Tobias Merseburger

    14. Chapter 14

      Waste Treatment Options, and the Environmental Impact of Single-Use Systems (pages 173–182)

      Urs Baier

    15. Chapter 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 Zheng

  3. Part II: Application Reports and Case Studies

    1. Chapter 16

      Disposable SuperSpinner: Characteristics and Typical Applications (pages 197–205)

      Andreas Kocourek, Jacqueline Herrmann, Lidija Lisica, Irina Bauer and Regine Eibl

    2. Chapter 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 Eibl

    3. Chapter 18

      Practical Aspects of Establishing Pharmaceutical Recombinant Proteins from Research to Development in Disposable Bioreactors (pages 215–223)

      Joerg Schmidt, Claudia Probst and Cornelia Fux

    4. Chapter 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 Reif

    5. Chapter 20

      Single-Use Bioreactor Platform for Microbial Fermentation (pages 241–250)

      Parrish M. Galliher, Geoff Hodge, Patrick Guertin, Lawrence Chew and Ted Deloggio

    6. Chapter 21

      Growth of BY-2 Suspension Cells and Plantibody Production in Single-Use Bioreactors (pages 251–261)

      Nicole Raven, Stefan Schillberg, Janina Kirchhoff, Johanna Brändli, Nicole Imseng and Regine Eibl

    7. Chapter 22

      CFD as a Tool to Characterize Single-Use Bioreactors (pages 263–279)

      Christian Löffelholz, Stephan C. Kaiser, Sören Werner and Dieter Eibl

    8. Chapter 23

      Automated Disposable Systems: Application Reports (pages 281–294)

      Nicola Franscini, Iris Poggendorf, Clara Cavelier, Jens M. Kelm, Wolfgang Moritz and Ursula Graf-Hausner

    9. Chapter 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-Keller

    10. Chapter 25

      Disposable Chromatography for Large-Scale Biomanufacturing (pages 301–309)

      André Pastor and Stéphan Barbe

    11. Chapter 26

      Single-Use Virus Clearance Technologies in Biopharmaceutical Manufacturing: Case Studies (pages 311–322)

      Suma Ray and Sherri Dolan

    12. Chapter 27

      A Single-Use Technology Platform for Downstream Processing: Mobius FlexReady Solutions (pages 323–331)

      Gerd Walter

    13. Chapter 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 Forss

    14. Chapter 29

      Going Fully Disposable—Current Possibilities: A Case Study from Crucell (pages 341–349)

      Alfred Luitjens and Alain Pralong

    15. Chapter 30

      Production Costs in Biotech Facilities: Single-Use versus Multiple-Use Equipment for Antibody Manufacture (pages 351–361)

      Anke Seeger and David Estapé

    1. You have free access to this content
      Index (pages 363–369)

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