In the development of novel substrates used for production of human vaccines there has been significant progress made in recent years. In addition, the high demand for vaccines in the industrialised countries has 11 x 17 paper chl qualification target pdf been paralleled by a steep increase in demand in developing countries. Using new cell substrates may prove to be a highly replication-proficient way of producing live viral vaccines such as Influenza A viruses.
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Despite some advantages, cell substrates may pose a small residual risk to humans since some of them are known to be tumourigenic in immunosuppressed animals. However, this residual risk should be considered acceptable by regulators. This paper considers the guidance contained in these regulatory documents. Even though there has been tremendous progress in the last few years, reflected mainly by revisions and updates to regulatory guidance documents, there still is still no consensus between regulators nor significant harmonisation of the guidance documents or monographs. Up-to-date regulatory requirements for cell substrate characterisation. Focus on the manufacture of live attenuated viral vaccines and its problems associated with downstream purification.
Focus on major concerns such as tumourigenicity and oncogenicity of PCC. Arbitrary risk based classification of cell substrates for the manufacture of vaccines for human use. Check if you have access through your login credentials or your institution. Strategies aimed at strengthening resilience protective factors provide a potential approach for reducing mental health problems in adolescents. This study evaluated the effectiveness of a universal, school-based intervention targeting resilience protective factors in reducing mental health problems in adolescents. A cluster randomised controlled trial was conducted in 20 intervention and 12 control secondary schools located in socio-economically disadvantaged areas of NSW, Australia.
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