On July 28, 2021 Bio-Techne Corporation (NASDAQ: TECH) and PROGEN reported the launch of the Simple Plex Adeno-Associated Virus (AAV2) viral titer assay for AAV2 total capsid quantification (Press release, Bio-Techne, JUL 28, 2021, View Source [SID1234585304]). Bio-Techne, owner of the leading ProteinSimple branded protein analysis portfolio of products, and PROGEN will offer the Simple Plex AAV2 viral titer assay on Ella instruments, its multiplexing immunoassay system. Combining the efficiency and reproducibility of the established AAV2 ELISAs from PROGEN with the convenient workflow and robustness of the Ella platform, the Simple Plex AAV2 viral titer assay offers a broad dynamic range and hands-free automation to accelerate cell and gene therapy process development. Featuring antibodies from PROGEN, the Simple Plex AAV2 viral titer assay detects assembled viral capsids as well as the comprehensively characterized AAV2 standard to deliver industry leading specificity.

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AAV2 is commonly used in gene transduction because of its ability to readily infect a variety of cell types. During the viral vector production process, a series of robust analytical measurements are required to determine the viral titer. The Simple Plex AAV2 assay features an automated workflow designed to minimize variability and ensure optimum and consistent quantitation throughout the viral purification process.

Available on the Ella platform, the Simple Plex AAV2 assay utilizes the recombinant AAV2 antibody (A20R) from industry leader PROGEN to quantify assembled AAV2 capsids. The AAV2 assay offers the same proven specificity as the industry standard PROGEN ELISA along with the convenience and simplicity of the fully automated Ella platform.

"As the cell and gene therapy field continues to expand, the ability to meet increased throughput and safety demands is critical," said Dave Eansor, President of BioTechne’s Protein Sciences division. "The Simple Plex AAV2 assay’s high sensitivity and broad dynamic range is particularly useful for AAV2 quantitation, providing researchers with a fully automated and quantitative method of vector analysis."

"Working with ProteinSimple to develop the Simple Plex AAV2 assay was a great experience," said Katja Betts, CEO of PROGEN. "As the leader in AAV capsid titer quantification and exclusive manufacturer of the most commonly used AAV antibodies and accompanying AAV ELISA kits, we are delighted to drive forward the development of robust & reliable quantification methods for the gene therapy community."

The Ella platform allows users to perform high-quality immunoassays with no manual intervention, delivering results in just 90 minutes and requiring only 50 µL of diluted sample. Factory calibration of each Simple Plex assay cartridge minimizes setup time and user error. Setting up an assay simply requires loading diluted samples into the cartridge. Once loaded, the Ella platform performs every step of the immunoassay automatically, from wash steps to final quantification of results.

PROGEN provides an exclusive portfolio of AAV antibodies including antibodies against intact AAV virus particles of which the A20R, used for the PROGEN AAV2 ELISAs as well as the Simple Plex AAV2 assay represents the most frequently used example. The AAV antibodies are also used for the analysis of AAV capsid integrity, purification and represent a suitable positive control for neutralization assays to analyze pre-existing AAV antibodies in patient sera. Due to their high affinity and specific binding to fully assembled AAV particles the PROGEN antibodies are well-established tools for AAV gene therapy R&D and quality control.