Vaccine Development and Manufacturing

Emily P. Wen, PhD, is currently a Research Fellow at the Merck Research Laboratory in the department of Vaccine Process Development. Dr. Wen has led process developments for several major vaccine products from Phase I to Phase III clinical trials, including vaccines against hepatitis B, Haemophilus influenzae type b, Pneumococcal, Meningococcal, and Group B Streptococcus.

Ronald J. Ellis, PhD, is Chief Technology Officer at FutuRx Ltd in Israel. Dr. Ellis has >30 years of industry experience in line and senior management in many companies, including roles as project leader and champion of projects that resulted in 5 licensed vaccines which accrue ~$4B in annual sales. He is the founding and incumbent Editor-in-Chief of the MedLine-/PubMed-indexed journal Human Vaccines & Immunotherapeutics.

Narahari S. Pujar, PhD, MBA, is currently an Executive Director and Integrated Product Leader in the Vaccine Business Line at Merck & Co., Inc.  Dr. Pujar has contributed to a variety of vaccines and biologics products and product candidates. He is an active member of the American Chemical Society and was the past chair of the Division of Biochemical Technology.

Anurag S. Rathore, PhD, is Professor in the Department of Chemical Engineering at IIT Delhi, India. He is an active member of the Parenteral Drug Association (PDA) and American Chemical Society (ACS) and have authored more than 200 publications and presentations in these areas.

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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