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Vaccine Development and Manufacturing. Wiley Series in Biotechnology and Bioengineering

  • ID: 2182304
  • Book
  • January 2015
  • Region: Global
  • 456 Pages
  • John Wiley and Sons Ltd
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Invaluable reference on how to produce a vaccine – from beginning to end

Vaccine production is a major unit of many pharmaceutical companies. With several biotechnology companies involved in developing new types of vaccines, tremendous advances are been observed continually in all aspects of vaccine manufacturing. Novel adjuvants discovered in recent years have shown great promises in human clinical trials by helping elicit stronger immune response and provide durable memory effects. New concepts in facility designs have enabled multiple use of the same facility. Vaccine Development and Manufacturing serves 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.

Vaccine Development and Manufacturing comprehensively covers a wide range of issues from:

  • Process perspective fermentation to purification to formulation developments
  • Production facility design to manufacturing
  • Regulatory perspective requirements from government agencies
  • Challenges and issues involved in manufacturing different types of vaccines

With contributions by authors from various major pharmaceutical and biotechnology companies, this book will be a resource for a plethora of experts, including R&D scientists, medical professionals, regulatory specialists, clinical researchers, manufacturing specialists, and quality–related personnel. This book will provide insights to the issues that scientists face and the steps involved in producing a vaccine, and will be a reference for state–of–the–art vaccine manufacturing technologies and facility set–up.

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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

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Emily P. Wen
Ronald Ellis
Narahari S. Pujar
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