Considerations in leveraging the Universal AAV Standard for dPCR to assess AAV genomes quantity and quality

Live30 webinars are thirty-minute presentations designed to update you on the latest innovations, applications, and data in a fast yet interactive format.

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.

Attend this webinar to:

• Learn about the Universal AAV Standard as a tool to assess AAV genome titer and genomic integrity
• Discover the role of dPCR in evaluating the quality and genomic integrity of AAV genomes produced with AE1-BHK using the Universal AAV Standard
• Understand the significance of novel AE1-BHK cell line as a AAV producer with the use of triple transfection-based production methods

Andrzej Noyszewski

Senior Scientist at Agathos Biologics

Andrzej Noyszewski, Senior R&D Scientist, is a biotechnology industry professional with subject matter expertise in synthetic gene constructs, analytical methods (DNA, mRNA, proteins), downstream processing and product development. Prior to his role at Agathos Biologics, Noyszewski worked as a part of the Analytical Methods Validation team at Aldevron, ND. He holds a Doctor of Philosophy (PhD) in Genomics and Bioinformatics from North Dakota State University and a Master of Science and Engineering (MSc. Eng) in Biotechnology from Warsaw University of Life Sciences in Warsaw.

Alex Deiulio

Scientist at Agathos Biologics

Alex Deiulio has been with Agathos Biologics since 2022 and is a Scientist with 6 years of experience in analytical method development, validation, and implementation. His responsibilities include developing various analytical methods to characterize AAV and support cell line development. Alex leads the analytical testing team at Agathos. Alex has been focused on using the QIAcuity dPCR to characterize the genomic integrity of Agathos’ Universal AAV Standard. Alex holds a B.S. in Molecular Biology from Indian River State College.