Universal AAV Standard
The Universal AAV Standard* is a reference material designed for AAV titer and genomic integrity control, enabling precise genome characterization using digital PCR platforms. It incorporates multiple genomic targets commonly used in gene therapy assays, allowing assessment of both vector copy number and genome integrity using combinations of PCR targets widely applied in gene therapy industry.
*Agathos Biologics materials used with permission.
A Recombinant Adeno-Associated Virus (rAAV) Universal Reference Standard for Determining rAAV Genome Copy Titer by Quantitative PCR. Agathos Biologics, LLC (assignee) – U.S. Patent Application No. 18/649,859 · Filed Apr 29, 2024
Genome Integrity Positive Control
Duplex dPCR assays revealed consistent AAV genome integrity across sites, with acceptable intra- and inter-assay precision. Integrity was highest for shorter amplicons near the gene of interest and decreased toward ITR-proximal regions, suggesting duplexes with larger separation are more prone to truncation. * – Duplex 2 not included in the cross-site evaluation.
*Agathos Biologics materials used with permission.
Titer Positive Control
Duplex dPCR assays* showed good agreement in AAV titer measurements between Agathos Biologics and Qiagen across multiple AAV genome targets. Titer differences remained within an acceptable range, supporting the reproducibility and robustness of the assay across laboratories. Data are shown as log₁₀-transformed titers.
*Agathos Biologics materials used with permission.
Certificate of Analysis (COA)
Each Universal AAV Standard is supplied with a Certificate of Analysis documenting key analytical attributes. Multiple AAV serotypes are available. The COA includes results from SDS-PAGE analysis for capsid purity, vector genome titer determined using eGFP-based assays, and genome titers measured using Qiagen CGT dPCR assays across all available PCR targets present on the Universal AAV Standard. ELISA-based capsid quantification is also provided.
Standards are supplied at a volume of 50 µL and are produced in the AE1-BHK cell line, developed by Agathos Biologics.
*Agathos Biologics materials used with permission.
Baby Hamster Kidney (BHK) Cells Transformed with the Adenoviral E1 Gene for Production of Recombinant Adeno-Associated Virus. Agathos Biologics, LLC (assignee) – U.S. Patent Application No. 2024/0263143 · Issued Feb 1, 2024
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