What are some successful approaches designed to minimize issues related to large scale manufacturability of viral vectors and its impact on environmental and regulatory risks?
One safety question regarding the large-scale manufacturability of viral vectors is the generation of replication-competent helper viruses during the packaging of the vector, which can occur by homologous recombination. Good laboratory practices are necessary to prevent any forms of contamination that may result in an opportunity for a replication-competent virus to form. Replication-competent virus testing is necessary. Because viral structural genes have been placed on different genetic units, multiple recombination events must occur before a replication competent helper virus is generated. Furthermore, areas of homology among the units expressing the helper virus proteins have been minimized. Also, heterologous promoters for the helper virus proteins are used. CDC-directed guidelines for BSL-2 + practices should dictate the handling of large amounts of virus and of concentrated virus. Sigma production facility conducts standardized operation procedure of testing for the spontaneous
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