Abstract: 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.
Type:
Grant
Filed:
July 29, 2016
Date of Patent:
May 26, 2020
Assignees:
The United States of America, as represented by the Secretary, Department of Health and Human Serv, American International Biotechnology, LLC
Inventors:
Trevor Lane Broadt, Michael D. Harwich, William T. Budd, Gregory A. Meyers
Abstract: 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.
Type:
Application
Filed:
July 29, 2016
Publication date:
August 23, 2018
Applicants:
The United States of America, as represented by the Secretary, Department of Health and Human Serv, American International Biotechnology, LLC
Inventors:
Trevor Lane Broadt, Michael D. Harwich, William T. Budd, Gregory A. Meyers