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