Lentivirus Titer and Structure
Lentivirus samples are super complex, making them tricky to analyze. This makes quick and easy monitoring of batch quality from crude all the way through the purification process a major challenge for rapid process development. On top of that, increasing focus from regulators on the need for analytical development and product characterization for lentivirus-based therapies makes understanding exactly what’s in your lentivirus batch more important than ever.
Current lentivirus analytical methods are limited in their ability to fully characterize crude virus, making it impossible to get accurate lentivirus titer determination, see if RNA is present, and monitor aggregation in early-stage samples. The p24 ELISA is the most common method for measuring physical lentivirus titer, while qPCR provides genomic titer. Both techniques only focus on one structural part of the virus – capsid or RNA. They also can’t handle unpurified samples with high levels of cellular contaminants and soluble p24. These assays leave you with a rough idea of how much p24 and RNA is in your prep but no clue as to whether they actually form viruses.
Technologies based on non-specific particle analysis offer an alternative to ELISA for physical lentivirus titer determination. These platforms can detect and count individual particles but make assumptions on their identity and content without directly checking what’s inside or on the surface.
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