Description
Book SynopsisVaccine Production and Manufacturing is a valuable reference on how to produce a vaccine, from beginning to end. It addresses all classes of vaccines from a processing, production, and regulatory viewpoint. It covers everything from fermentation, purification, and formulation to regulatory filing and facility design.
Table of ContentsAcknowledgments 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
