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The Universal AAV Standard is a new offering that can be used in the gene therapy landscape to ensure consistency and reliability of digital PCR (dPCR) measurements in AAV-based therapy products and research. It includes specifically designed AAV vectors for calibrating dPCR assays and equipment, with applications including assay development, quality control, and regulatory compliance. Furthermore, it may aid in meeting regulatory requirements from bodies such as the US FDA and EMA.
In this webinar we will explore the utility of a Universal AAV Standard in assessing the quantity and genomic integrity of AAV vectors. The Universal AAV Standard combines multiple target sites for commonly used promoters, poly(A) regions and functional CDS. Stacking of these elements in Universal AAV Standard allows it to serve as a single positive control for evaluating the performance of dPCR assays and assessing the quantity, quality, and genomic integrity of AAV genomes.
This approach adds convenience when evaluating gene therapy products that incorporate a variety of commonly used genetic elements using a single positive control. These target sites were selected based on QIAcuity Cell and Gene Therapy dPCR Assays and are broadly used in gene therapy products. The Universal AAV Standard was produced with a novel AE1-BHK cell line with use of triple transfection protocol.
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