Wen / Ellis / Pujar Vaccine Development and Manufacturing

1. Auflage 2014
ISBN: 978-1-118-87090-7
Verlag: John Wiley & Sons
Format: EPUB
Kopierschutz: 0 - No protection

E-Book, Englisch, 456 Seiten, E-Book

Reihe: Wiley Series on Biotechnology

Vaccine Manufacturing and Production is an invaluablereference on how to produce a vaccine - from beginning to end -addressing all classes of vaccines from aprocessing, production, and regulatory viewpoint. It willprovide comprehensive information on the various fields involved inthe production of vaccines, from fermentation, purification,formulation, to regulatory filing and facility designs. In recentyears, there have been tremendous advances in all aspects ofvaccine manufacturing. Improved technology and growth media havebeen developed for the production of cell culture with high celldensity or fermentation. Vaccine Manufacturing andProduction will serve as a reference on all aspects of vaccineproduction by providing an in-depth description of the availabletechnologies for making different types of vaccines and the currentthinking in facility designs and supply issues. This book willprovide insight to the issues scientists face when producing avaccine, the steps that are involved, and will serve asa reference tool regarding state-of-the-art vaccinemanufacturing technologies and facility set-up.
Highlights include:
* Comprehensive coverage of vaccine production : from a processpoint of view- fermentation to purification to formulationdevelopments; from a production point of view - from facilitydesign to manufacturing; and from a regulatory point of view -requirements from government agencies
* Authors from different major pharmaceutical and biotechnologycompanies
* Describes the challenges and issues involved in vaccineproduction and manufacturing of the different classes of vaccines,an area not covered by other books currently on the market

Autoren/Hrsg.

Wen, Emily P.

Ellis, Ronald

Pujar, Narahari S.

Inhaltsverzeichnis

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: ANovel Bacterial-Based Vaccine Production Platform 25
Michel Chartrain
3 Fungal Expression Systems for Vaccine Production 51
Karl Melber, Volker Jenzelewski, Roland Weyhenmeyer, andZbigniew 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, andEric J. Patzer
11 Production and Characterization of Aluminum-ContainingAdjuvants 319
Stanley L. Hem and Cliff T. Johnston
12 The Biologics License Application (BLA) in Common TechnicalDocument (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 DesignApproach 393
Anand Ekambaram and Abraham Shamir
15 Vaccine Production Economics 413
Andrew Sinclair and Peter Latham
Index 437

Über Autor(innen)

Emily P. Wen, PhD, is currently a Research Fellow at theMerck Research Laboratory in the department of Vaccine ProcessDevelopment. Dr. Wen has led process developments forseveral major vaccine products from Phase I to Phase III clinicaltrials, including vaccines against hepatitis B, Haemophilusinfluenzae type b, Pneumococcal, Meningococcal, and Group BStreptococcus.
Ronald J. Ellis, PhD, is Chief Technology Officer atFutuRx Ltd in Israel. Dr. Ellis has >30 years of industryexperience in line and senior management in many companies,including roles as project leader and champion of projects thatresulted in 5 licensed vaccines which accrue ~$4B in annualsales. He is the founding and incumbent Editor-in-Chiefof the MedLine-/PubMed-indexed journal Human Vaccines &Immunotherapeutics.
Narahari S. Pujar, PhD, MBA, is currently an ExecutiveDirector and Integrated Product Leader in the Vaccine Business Lineat Merck & Co., Inc. Dr. Pujar has contributed to avariety of vaccines and biologics products and product candidates.He is an active member of the American Chemical Society and was thepast chair of the Division of Biochemical Technology.
Anurag S. Rathore, PhD, is Professor in the Department ofChemical Engineering at IIT Delhi, India. He is an active member ofthe Parenteral Drug Association (PDA) and American Chemical Society(ACS) and have authored more than 200 publications andpresentations in these areas.