Del 5 - Wiley Series in Biotechnology and Bioengineering

Vaccine Development and Manufacturing

Inbunden, Engelska, 2015

AvEmily P. Wen,Emily P. Wen,Ronald Ellis,Narahari S. Pujar,Emily P Wen,Narahari S Pujar

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Vaccine Manufacturing and Production is an invaluable reference on how to produce a vaccine - from beginning to end - addressing all classes of vaccines from a processing, production, and regulatory viewpoint. It will provide comprehensive information on the various fields involved in the production of vaccines, from fermentation, purification, formulation, to regulatory filing and facility designs. In recent years, there have been tremendous advances in all aspects of vaccine manufacturing. Improved technology and growth media have been developed for the production of cell culture with high cell density or fermentation. 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. Highlights include: Comprehensive coverage of vaccine production : from a process point of view- fermentation to purification to formulation developments; from a production point of view - from facility design to manufacturing; and from a regulatory point of view - requirements from government agenciesAuthors from different major pharmaceutical and biotechnology companiesDescribes the challenges and issues involved in vaccine production and manufacturing of the different classes of vaccines, an area not covered by other books currently on the market

Produktinformation

Utgivningsdatum2015-01-20
Mått163 x 243 x 28 mm
Vikt753 g
FormatInbunden
SpråkEngelska
SerieWiley Series in Biotechnology and Bioengineering
Antal sidor464
FörlagJohn Wiley & Sons Inc
ISBN9780470261941

Tillhör följande kategorier

Tillverkningsteknik inom Naturvetenskap och teknik
Farmakologi inom Medicin

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 ELLIS, PhD, is Chief Technology Officer at FutuRx Ltd in Israel. Dr. Ellis has more than 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 five 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.

Acknowledgments viiPreface ixContributors xi1 History of Vaccine Process Development 1Narahari S. Pujar, Sangeetha L. Sagar, and Ann L. Lee2 The Production of Plasmid DNA Vaccine in Escherichia coli: A Novel Bacterial-Based Vaccine Production Platform 25Michel Chartrain3 Fungal Expression Systems for Vaccine Production 51Karl Melber, Volker Jenzelewski, Roland Weyhenmeyer, and Zbigniew Janowicz4 Novel Expression Systems for Vaccine Production 81Shailaja Rabindran and Vidadi Yusibov5 Viral Vaccines Purification 97Bernd Kalbfuss-Zimmermann and Udo Reichl6 Protein Subunit Vaccine Purification 181Yan-ping Yang and Tony D’Amore7 Conjugate Vaccine Production Technology 217Sudha Chennasamudram and Willie F. Vann8 Stabilization and Formulation of Vaccines 237Timothy S. Priddy and C. Russell Middaugh9 Lyophilization in Vaccine Processes 263Alexis Wasserman, Ranjit Sarpal, and Bret R. Phillips10 Strategies for Heat-Stable Vaccines 287Satoshi Ohtake, David Lechuga-Ballesteros, Vu Truong-Le, and Eric J. Patzer11 Production and Characterization of Aluminum-Containing Adjuvants 319Stanley L. Hem and Cliff T. Johnston12 The Biologics License Application (BLA) in Common Technical Document (CTD) Format 347R.S. Robin Robinett13 The Original New Drug Application (Investigational New Drug) 373R.S. Robin Robinett14 Facility Design for Vaccine Manufacturing—Regulatory, Business, and Technical Considerations and A Risk-Based Design Approach 393Anand Ekambaram and Abraham Shamir15 Vaccine Production Economics 413Andrew Sinclair and Peter LathamIndex 437