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Vaccine Analysis: Strategies, Principles, and Control (英语) 精装 – 2014年12月9日 c2 q+ B9 w" S# C- r4 {0 ?! l3 b/ Z
Brian K. Nunnally (编者), Vincent E. Turula (编者), Robert D. Sitrin (编者)
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, n8 Q. o2 I7 }This book is an indispensable tool for anyone involved in the research, development, or manufacture of new or existing vaccines. It describes a wide array of analytical and quality control technologies for the diverse vaccine modalities.7 Z" _7 I% a1 ]' g0 x2 @: O! |
Topics covered include the application of both classical and modern bio-analytical tools; procedures to assure safety and control of cross contamination; consistent biological transition of vaccines from the research laboratory to manufacturing scale; whole infectious attenuated organisms, such as live-attenuated and inactivated whole-cell bacterial vaccines and antiviral vaccines using attenuated or inactivated viruses; principles of viral inactivation and the application of these principles to vaccine development; recombinant DNA approaches to produce modern prophylactic vaccines; bacterial subunit, polysaccharide and glycoconjugate vaccines; combination vaccines that contain multiple antigens as well as regulatory requirements and the hurdles of licensure.
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