Vaccine Development & Manufacturing

9,940.27

ISBN: 9780470261941
Author/Editor: Emily P. Wen

Publisher: John Wiley

Year: 2015

1 in stock (can be backordered)

SKU: ABD-JW-12 Category:

Description

Vaccine Manufacturing and Production is an invaluable reference on how to produce a vaccine – from beginning to end – addressing all classes of vaccines from a processing, production, and regulatory viewpoint. It will provide comprehensive information on the various fields involved in the production of vaccines, from fermentation, purification, formulation, to regulatory filing and facility designs. In recent years, there have been tremendous advances in all aspects of vaccine manufacturing. Improved technology and growth media have been developed for the production of cell culture with high cell density or fermentation. Vaccine Manufacturing and Production will serve as a reference on all aspects of vaccine production by providing an in-depth description of the available technologies for making different types of vaccines and the current thinking in facility designs and supply issues. This book will provide insight to the issues scientists face when producing a vaccine, the steps that are involved, and will serve as a reference tool regarding state-of-the-art vaccine manufacturing technologies and facility set-up.
Highlights include: * Comprehensive coverage of vaccine production : from a process point of view- fermentation to purification to formulation developments; from a production point of view – from facility design to manufacturing; and from a regulatory point of view – requirements from government agencies * Authors from different major pharmaceutical and biotechnology companies * Describes the challenges and issues involved in vaccine production and manufacturing of the different classes of vaccines, an area not covered by other books currently on the market

Additional information

Weight 0.76 kg

Product Properties

Year of Publication

2015

Table of Contents

Acknowledgments vii Preface ix Contributors xi 1 History of Vaccine Process Development 1 Narahari S. Pujar, Sangeetha L. Sagar, and Ann L. Lee 2 The Production of Plasmid DNA Vaccine in Escherichia coli: A Novel Bacterial-Based Vaccine Production Platform 25 Michel Chartrain 3 Fungal Expression Systems for Vaccine Production 51 Karl Melber, Volker Jenzelewski, Roland Weyhenmeyer, and Zbigniew Janowicz 4 Novel Expression Systems for Vaccine Production 81 Shailaja Rabindran and Vidadi Yusibov 5 Viral Vaccines Purification 97 Bernd Kalbfuss-Zimmermann and Udo Reichl 6 Protein Subunit Vaccine Purification 181 Yan-ping Yang and Tony D Amore 7 Conjugate Vaccine Production Technology 217 Sudha Chennasamudram and Willie F. Vann 8 Stabilization and Formulation of Vaccines 237 Timothy S. Priddy and C. Russell Middaugh 9 Lyophilization in Vaccine Processes 263 Alexis Wasserman, Ranjit Sarpal, and Bret R. Phillips 10 Strategies for Heat-Stable Vaccines 287 Satoshi Ohtake, David Lechuga-Ballesteros, Vu Truong-Le, and Eric J. Patzer 11 Production and Characterization of Aluminum-Containing Adjuvants 319 Stanley L. Hem and Cliff T. Johnston 12 The Biologics License Application (BLA) in Common Technical Document (CTD) Format 347 R.S. Robin Robinett 13 The Original New Drug Application (Investigational New Drug) 373 R.S. Robin Robinett 14 Facility Design for Vaccine Manufacturing Regulatory, Business, and Technical Considerations and A Risk-Based Design Approach 393 Anand Ekambaram and Abraham Shamir 15 Vaccine Production Economics 413 Andrew Sinclair and Peter Latham Index 437

Author

Emily P. Wen

ISBN/ISSN

9780470261941

Binding

Hardback

Edition

1

Publisher

John Wiley

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