Researchers at the National Cancer Institute’s Biopharmaceutical Development Program recently developed massively parallel sequencing methods for virus-derived therapeutics such as viral vaccines and oncolytic immunotherapies. The methods allow for the determination of micro-heterogeneity and quantitation of low frequency sequence variants, which have the possibility of supplanting monkey neurovirulence safety testing (MNVT), mutant analysis by PCR, and restriction enzyme cleavage (MAPREC) methods that are currently used to screen RNA virus-derived therapeutics. The technology is currently in clinical stage.

Competitive Advantages:

• Provides a cost- and time-effective means of assaying a virus-derived therapeutic, such as oncolytic viruses, for viral sequence variants, for regulatory approval;
• RNA virus preparation steps increase the amount of viral RNA obtained;
• Demonstrated superiority of massively parallel sequencing (“MPS”) over mutant analysis by PCR and restriction enzyme cleavage (“MAPREC”) analysis.

Commercial Applications:

• Improved methods for detecting mutations in GMP-manufactured virus-derived therapeutics, including viruses, viral template plasmids, or vaccines;
• The method allows for at least two different virus-derived therapeutics to be assayed simultaneously.