Simplifying lentiviral downstream processing with a novel affinity resin & robust analytical tools

Recombinant lentivirus has become a vector of choice for many gene-modified cell therapies, including several US Food and Drug Administration-approved cell therapies, due to its broad tropism and long-term, stable gene expression in non-dividing cells. The safety and efficacy of lentiviral-based therapies depend greatly on optimized and controlled lentiviral production. Downstream purification of lentiviral particles presents unique challenges, and robust analytics are critical to verify both the recovery and infectivity of the purified product. In this article, an overview of challenges and newly developed solutions for robust lentiviral purification and rapid analytical methods for titer determination and impurity quantification will be presented. Details of a new affinity chromatography resin to purify vesicular stomatitis virus glycoprotein pseudotyped lentivirus, as well as two qPCR-based genomic and proviral infectious titer assays, will be discussed.

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