Methods of analyzing virus-derived therapeutics

Described herein are massively parallel sequencing methods for virus-derived therapeutics such as viral vaccines, including the PVS-RIPO vaccine. The methods allow for the determination of micro-heterogeneity and quantitation of low frequency sequence variants and in the case of PVS-RIPO, are expect...

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Bibliographische Detailangaben
Hauptverfasser: Broadt, Trevor Lane, Harwich, Michael D, Meyers, Gregory A, Budd, William T
Format: Patent
Sprache:eng
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Beschreibung
Zusammenfassung:Described herein are massively parallel sequencing methods for virus-derived therapeutics such as viral vaccines, including the PVS-RIPO vaccine. The methods allow for the determination of micro-heterogeneity and quantitation of low frequency sequence variants and in the case of PVS-RIPO, are expected to replace the monkey neurovirulence safety test (MNVT) and the mutant analysis by PCR and restriction enzyme cleavage (MAPREC) methods that are currently used to screen lots of RNA virus-derived therapeutics.