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.

Table of Contents

• Acknowledgments
• Preface
• Contributors
• History of Vaccine Process Development - Narahari S. Pujar, Sangeetha L. Sagar, Ann L. Lee
• The Production of Plasmid DNA Vaccine in E: A Novel Bacterial-Based Vaccine Production Platform - Michel Chartrain
• Fungal Expression Systems for Vaccine Production - Karl Melber, Volker Jenzelewski, Roland Weyhenmeyer, Zbigniew Janowicz
• Novel Expression Systems for Vaccine Production - Shailaja Rabindran, Vidadi Yusibov
• Viral Vaccines Purification - Bernd Kalbfuss-Zimmermann, Udo Reichl
• Protein Subunit Vaccine Purification - Yan-ping Yang, Tony D'Amore
• Conjugate Vaccine Production Technology - Sudha Chennasamudram, Willie F. Vann
• Stabilization and Formulation of Vaccines - Timothy S. Priddy, C. Russell Middaugh
• Lyophilization In Vaccine Processes - Alexis Wasserman, Ranjit Sarpal, Bret R. Phillips
• Strategies for Heat-Stable Vaccines - Satoshi Ohtake, David Lechuga-Ballesteros, Vu Truong-Le, Eric J. Patzer
• Production And Characterization Of Aluminum-Containing Adjuvants - Stanley L. Hem, Cliff T. Johnston
• The Biologics License Application (BLA) in Common Technical Document (CTD) Format - R.S. Robin Robinett
• The Original New Drug Application (Investigational New Drug) - R.S. Robin Robinett
• Facility Design for Vaccine Manufacturing—Regulatory, Business, and Technical Considerations and a Risk-Based Design Approach - Anand Ekambaram, Abraham Shamir
• Vaccine Production Economics - Andrew Sinclair, Peter Latham