Characterization Of Lentiviral Vector Quality Attributes Using Capillary Electrophoresis (CE) Platform Technology

By Aaron Shafer, Alicia Powers, Yan Lu, Chao-Xuan Zhang, Timothy Lockey, Catherine Willis, Michael Meagher, Tingting Li, Jane Luo, Mario Pulido and Sahana Mollah, St. Jude Children's Research Hospital, USA SCIEX, USA

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Review this outline of a platform-based approach using capillary electrophoresis (CE) to mitigate the technical difficulties in characterizing LVVs for the assessment of multiple quality attributes. CE technology demonstrates unique capabilities for quality attribute monitoring of LVVs at both protein and genome levels.

Key features of this platform-based approach include:

• Robust methods to characterize and monitor quality attributes of LVVs at both protein and genome levels using a CE-based platform
• Protein analysis using a CGE-SDS-LIF workflow provides the p24 titer and the protein profile of LVV samples
• Genomic analysis using a CGE-LIF workflow provides information on the genome integrity as well as the residual nucleic acids in LVV samples
• The multiplexing ability of the BioPhase 8800 system expedites the comprehensive characterization of LVV products to enable faster decision making during process development and streamline quality monitoring during the downstream purification process