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STRONGLY INACTIVATED IMMUNOGENOUS VACCINE, PRESERVING HIGH IMMUNOGENITY, AND METHOD FOR ITS MANUFACTURE
专利权人:
НЕОВАКС (FR)
发明人:
ГРУАР-ВОЖЕЛЬ Жеральдин (FR),ДЕЛЛИН Оливье (FR),ФАНЖЕ Бернар (FR),ВАНДЕПАПЕЛЬЕР Пьер (BE)
申请号:
RU2013125147/15
公开号:
RU2013125147A
申请日:
2011.12.08
申请国别(地区):
RU
年份:
2015
代理人:
摘要:
1. An immunogenic product containing TNFα associated with KLH, where TNFα is strongly inactivated, which means that the product at a concentration of 100 ng / ml shows less than 30% cytolytic activity and / or inactivation coefficient above 15000 under TEST A.2. The immunogenic product according to claim 1, characterized in that said product remains inactivated over time, which means that said product at a concentration of 100 ng / ml shows less than 80% cytolytic activity and / or an inactivation coefficient above 500 under TEST B.3 conditions. . The immunogenic product according to claim 1, characterized in that said product possibly contains free TNFα homopolymers weighing more than 300 kDa, and if said product contains free TNFα homopolymers weighing more than 300 kDa, the percentage of free TNFα homopolymers weighing more than 3000 kDa is less than 30% by mass. / mass total TNFα according to the results of TEST C.4. The immunogenic product according to claim 2, characterized in that said product possibly contains free TNFα homopolymers weighing more than 300 kDa, and if said product contains free TNFα homopolymers weighing more than 300 kDa, the percentage of free TNFα homopolymers weighing more than 300 kDa is less than 30 wt%. / mass total TNFα according to the results of TEST C.5. An immunogenic product according to any one of claims 1 to 4, characterized in that said product is lyophilized. An immunogenic emulsion containing the product according to any one of claims 1 to 5; and oil and a surfactant or mixture thereof; where the emulsion is an oil in water emulsion or a water in oil emulsion, and wherein the oil, surfactant and / or mixture of oil and surfactant are1. Иммуногенный продукт, содержащий ФНОα, связанный с KLH, где ФНОα сильно инактивирован, что означает, что продукт в концентрации 100 нг/мл демонстрирует менее 30% цитолитической активности и/или коэффициент инактивации выше 15000 в условиях ТЕСТА A.2. Иммуногенный продукт по п.1, отличающийся т
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