Although delivery of gene therapy using viral vectors holds tremendous promise, the stringent and time-consuming process control measures to ensure safety, track efficacy, and achieve acceptable throughputs remain significant hurdles for clinical success. The need to accurately measure capsid concentration across each unit operation is particularly important with adeno-associated virus (AAV), which has emerged as a leading delivery vector thanks to its ability to readily infect a variety of cells.
To scale AAV process development analytics, Bio-Techne Corporation and PROGEN partnered to pair BioTechne’s Simple Plex™ microfluidic cartridge immunoassays with PROGEN’s best-in-class AAV reagents. The result—three new Simple Plex AAV viral titer assays for intact AAV capsid quantification (AAV1, AAV6, and AAV8). The assays provide users with a fully automated and quantitative method for accurate and efficient titration of AAV particles with the same superior performance as industry standard PROGEN AAV ELISAs.
Available for the automated Ella platform, the Simple Plex AAV viral titer assays deliver both the specificity of PROGEN’s extensively characterized serotype-specific antibodies, to help ensure reliable AAV quantification, and the reproducibility and time savings inherent in the hands-free Ella workflow. Superior precision and a wide dynamic range help ensure consistent and reproducible data needed for meeting regulatory standards for AAV titration. The dynamic range also means fewer dilutions to meet the linear range of the assay.
Linear correlations of the Simple Plex AAV assays and PROGEN AAV ELISAs show nearly perfect correlation where the quantitative range of both assays overlap. Testing also reveals consistent linearity across four dilution points, with all percent recoveries falling between 80 and 120 percent. The results demonstrate how the sensitive nature of PROGEN antibodies translates well to the robust performance of the Simple Plex AAV assays on the Ella platform.
The new Simple Plex AAV™ assays offer a robust alternative to the conventional ELISA or dot blot approaches for fast and efficient AAV capsid titer quantification. The hands-free Ella platform eliminates the tedious manual steps that come with running a traditional immunoassay, helping to accelerate time to result and reduce human error—both factors that adversely impact assay reproducibility and team productivity.