Определение гемагглютинина методом орид — самая критическая стадия производства вирусинактивированных гриппозных вакцин? (стр. 4 )

Посткриптум.         Большой помощью для всего сообщества производителей инактивированных гриппозных вакцин была бы общепринятая положительная практика EDQM, заключающаяся в подключении международных экспертов Европейского и международного сообщества к снятию большинства вышеуказанных проблемных вопросов к ОРИД и завершившаяся бы в итоге включением в раздел «Методы анализа» Европейской Фармакопеи специального подраздела или опубликованием стандартной операционной процедуры на получение референс антигена (гемагглютинина),  референс антисыворотки,  и, собственно, на метод ОРИД в Pharmeuropa Bio & Scientific Notes (официальное издание EDQM).  Необходимо также дальнейшее продолжение международных экспертных исследований по законодательному утверждению альтернативных методов количественного определения гемагглютинина,  обладающих высокой корреляцией с методом ОРИД.

Литература

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