Titlebook: Vaccine Analysis: Strategies, Principles, and Control; Brian K. Nunnally,Vincent E. Turula,Robert D. Sitr Book 2015 Springer-Verlag Berlin

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Recombinant Virus-like Particle Protein Vaccines,Viral diseases offer a major challenge to vaccine development because of the complex nature of virus structures and the large size of the virus particle needed to generate an effective immune response. Viral diseases frequently stimulate both Th2 (antibody-mediated) and Th1 (cell-mediated) immune pathways.

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Vaccines in Research and Development: New Production Platforms and New Biomolecular Entities for NeCurrently licensed vaccines have emanated from a relatively small number of production platforms. As shown in Table 9.1, these platforms have produced a large number of licensed products and are currently being used to develop a significant number of new vaccines that are currently under clinical evaluation.

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Establishing a Shelf Life and Setting Lot-Release Specifications,Potency is a critical quality attribute of a vaccine and those attributes that impact potency are essential to assuring vaccine quality. Over its entire shelf life, a vaccine must exceed a minimal potency value and, when defined, cannot exceed a maximal potency.

Adenoma

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978-3-662-52266-0Springer-Verlag Berlin Heidelberg 2015

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Live-Attenuated and Inactivated Whole-Cell Bacterial Vaccines,ow-income countries; and cholera vaccines which are used mainly by travelers to endemic areas, and to a lesser extent to control infections in endemic or epidemic settings. The production of live-attenuated and killed vaccines has been troubled historically by issues of quality and poor efficacy. In

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