1.

Record Nr.

UNINA9910785689903321

Titolo

Single-use technology in biopharmaceutical manufacture / / edited by Regine Eibl, Dieter Eibl

Pubbl/distr/stampa

Hoboken, N.J. : , : John Wiley & Sons, , 2010

ISBN

0-470-92276-1

1-283-91603-7

0-470-90999-4

0-470-90998-6

Descrizione fisica

1 online resource (xviii, 369, [2] pages) : illustrations

Altri autori (Persone)

EiblRegine

EiblDieter

Disciplina

615/.19

Soggetti

Pharmaceutical biotechnology

Medical supplies, Disposable

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Nota di bibliografia

Includes bibliographical references and index.

Nota di contenuto

SINGLE-USE TECHNOLOGY IN BIOPHARMACEUTICAL MANUFACTURE; Contents; Nomenclature; Preface; Contributors; PART I: Basics; CHAPTER 1: Single - Use Equipment in Biopharmaceutical Manufacture: A Brief Introduction; CHAPTER 2: Single - Use Bag Systems for Storage, Transportation, Freezing, and Thawing; CHAPTER 3: Bag Mixing Systems for Single - Use; CHAPTER 4: Single - Use Bioreactors -An Overview; CHAPTER 5: Systems for Coupling and Sampling; CHAPTER 6: Disposable Sensor Systems; CHAPTER 7: Bioinformatics and Single Use; CHAPTER 8: Single - Use Downstream Equipment

CHAPTER 9: Single - Use Technology for Formulation and Filling ApplicationCHAPTER 10: Production of Disposable Bags: A Manufacturer's Report; CHAPTER 11: Disposable Filter Devices; CHAPTER 12: Biopharmaceutical Manufacturing Facilities Integrating Single - Use Systems; CHAPTER 13: An Introduction to the Validation and Qualification of Disposables Used in Biomanufacture- A User ' s Perspective; CHAPTER 14: Waste Generation,Treatment Options, and the Environmental Impact of Single - Use Systems

CHAPTER 15: Next - Generation Single - Use Bioreactor Technology and



the Future of Biomanufacturing:A Summary from the Manufacturer 's and User's PerspectivePART II : Application Reports and Case Studies; CHAPTER 16: Disposable Super Spinner: Characteristics and Typical Applications; CHAPTER 17: A New Scale - Down Approach for the Rapid Development of Sf21/ BEVS - Based Processes - A Case Study; CHAPTER 18: Practical Aspects of Establishing Pharmaceutical Recombinant Proteins from Research to Development in Disposable Bioreactors

CHAPTER 19: Single - Use Stirred Tank Reactor BIOSTAT CultiBag STR :Characterization and ApplicationsCHAPTER 20: Single - Use Bioreactor Platform for Microbial Fermentation; CHAPTER 21: Growth of BY - 2 Suspension Cells and Plantibody Production in Single - Use Bioreactors; CHAPTER 22: CFD as a Tool to Characterize Single - Use Bioreactors; CHAPTER 23: Automated Disposable Systems: Application Reports; CHAPTER 24: New Single - Use Sensors for Online Measurement of Glucose and Lactate: The Answer to the PAT Initiative; CHAPTER 25: Disposable Chromatography for Large - Scale Biomanufacturing

CHAPTER 26: Single - Use Virus Clearance Technologies in Biopharmaceutical Manufacturing: Case StudiesCHAPTER 27: A Single - Use Technology Platform for Downstream Processing: Mobius Flex Ready Solutions; CHAPTER 28: The Manufacture of mAbs -A Comparison of Performance and Process Time between Traditional and Ready - to - Use Disposable Systems; CHAPTER 29: Going Fully Disposable - Current Possibilities: A Case Study from Crucell; CHAPTER 30: Production Costs in Biotech Facilities: Single - Use versus Multiple - Use Equipment for Antibody Manufacture; Index; colour plate

Sommario/riassunto

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.