{"product_id":"vaccine-development-and-manufacturing-isbn-9780470261941","title":"Vaccine Development and Manufacturing","description":"\u003cp\u003e\u003ci\u003eVaccine Manufacturing and Production\u003c\/i\u003e 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. \u003ci\u003eVaccine Manufacturing and Production\u003c\/i\u003e 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.\u003cbr\u003e \u003cbr\u003e Highlights include:\u003cbr\u003e \u003cbr\u003e \u003c\/p\u003e \u003cul\u003e \u003cli\u003eComprehensive 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 agencies\u003c\/li\u003e \u003cli\u003eAuthors from different major pharmaceutical and biotechnology companies\u003c\/li\u003e \u003cli\u003eDescribes 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\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eAcknowledgments vii\u003c\/p\u003e \u003cp\u003ePreface ix\u003c\/p\u003e \u003cp\u003eContributors xi\u003c\/p\u003e \u003cp\u003e1 History of Vaccine Process Development 1\u003cbr\u003e\u003ci\u003eNarahari S. Pujar, Sangeetha L. Sagar, and Ann L. Lee\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e2 The Production of Plasmid DNA Vaccine in \u003ci\u003eEscherichia coli\u003c\/i\u003e: A Novel Bacterial-Based Vaccine Production Platform 25\u003cbr\u003e\u003ci\u003eMichel Chartrain\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e3 Fungal Expression Systems for Vaccine Production 51\u003cbr\u003e\u003ci\u003eKarl Melber, Volker Jenzelewski, Roland Weyhenmeyer, and Zbigniew Janowicz\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e4 Novel Expression Systems for Vaccine Production 81\u003cbr\u003e\u003ci\u003eShailaja Rabindran and Vidadi Yusibov\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e5 Viral Vaccines Purification 97\u003cbr\u003e\u003ci\u003eBernd Kalbfuss-Zimmermann and Udo Reichl\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e6 Protein Subunit Vaccine Purification 181\u003cbr\u003e\u003ci\u003eYan-ping Yang and Tony D’Amore\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e7 Conjugate Vaccine Production Technology 217\u003cbr\u003e\u003ci\u003eSudha Chennasamudram and Willie F. Vann\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e8 Stabilization and Formulation of Vaccines 237\u003cbr\u003e\u003ci\u003eTimothy S. Priddy and C. Russell Middaugh\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e9 Lyophilization in Vaccine Processes 263\u003cbr\u003e\u003ci\u003eAlexis Wasserman, Ranjit Sarpal, and Bret R. Phillips\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e10 Strategies for Heat-Stable Vaccines 287\u003cbr\u003e\u003ci\u003eSatoshi Ohtake, David Lechuga-Ballesteros, Vu Truong-Le, and Eric J. Patzer\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e11 Production and Characterization of Aluminum-Containing Adjuvants 319\u003cbr\u003e\u003ci\u003eStanley L. Hem and Cliff T. Johnston\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e12 The Biologics License Application (BLA) in Common Technical Document (CTD) Format 347\u003cbr\u003e\u003ci\u003eR.S. Robin Robinett\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e13 The Original New Drug Application (Investigational New Drug) 373\u003cbr\u003e\u003ci\u003eR.S. Robin Robinett\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e14 Facility Design for Vaccine Manufacturing—Regulatory, Business, and Technical Considerations and A Risk-Based Design Approach 393\u003cbr\u003e\u003ci\u003eAnand Ekambaram and Abraham Shamir\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e15 Vaccine Production Economics 413\u003cbr\u003e\u003ci\u003eAndrew Sinclair and Peter Latham\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eIndex 437\u003c\/p\u003e  \u003cp\u003e\u003cb\u003eEMILY P. WEN, PhD,\u003c\/b\u003e 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. \u003c\/p\u003e\u003cp\u003e\u003cb\u003eRONALD ELLIS, PhD,\u003c\/b\u003e 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 \u0026amp; Immunotherapeutics. \u003c\/p\u003e\u003cp\u003e\u003cb\u003eNARAHARI S. PUJAR, PhD, MBA,\u003c\/b\u003e is currently an Executive Director and Integrated Product Leader in the Vaccine Business Line at Merck \u0026amp; 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.   \u003c\/p\u003e\u003cp\u003e\u003cb\u003eInvaluable reference on how to produce a vaccine—from beginning to end\u003c\/b\u003e  \u003c\/p\u003e\u003cp\u003eVaccine 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. \u003ci\u003eVaccine Development and Manufacturing\u003c\/i\u003e 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. \u003c\/p\u003e\u003cp\u003e\u003ci\u003eVaccine Development and Manufacturing\u003c\/i\u003e comprehensively covers a wide range of issues from the following: \u003c\/p\u003e\u003cul\u003e \u003cli\u003eProcess perspective—fermentation to purification to formulation developments\u003c\/li\u003e \u003cli\u003eProduction—facility design to manufacturing\u003c\/li\u003e \u003cli\u003eRegulatory perspective—requirements from government agencies\u003c\/li\u003e \u003cli\u003eChallenges and issues involved in manufacturing different types of vaccines\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eWith contributions by authors from various major pharmaceutical and biotechnology companies, this book will be a resource for a plethora of experts, including R\u0026amp;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 setup.\u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47990443671781,"sku":"NP9780470261941","price":166.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9780470261941.jpg?v=1761787851","url":"https:\/\/k12savings.com\/es\/products\/vaccine-development-and-manufacturing-isbn-9780470261941","provider":"K12savings","version":"1.0","type":"link"}