Accelerate Assay Development and Reduce Cycle Times for AAV Quantification in Complex Biological Samples

Recombinant Adeno-associated viruses (rAAVs) are among the most important gene delivery vehicles for in vivo gene therapy applications, with more than 255 clinical trials over the past 25 years. Therefore, the assessment of titers, integrity, and other critical quality attributes (CQAs) of AAV vectors has become a pressing issue in manufacturing.

In the process of developing their own AAV platform, ExcellGene faced the need for a potent and robust method for the assessment of titers and quality of AAV viral particles present at different steps in the manufacturing process. However, the use of serotype-specific ELISA as the current gold standard method is not only time consuming, with a turnaround time of four to five hours, but also prone to significant matrix effects.

The use of a label-free approach not only helped in reducing these effects in complex biological matrices, but also allowed ExcellGene to set up a routine method easily and rapidly for the high-throughput and automated analysis of up to 96 samples in less than 30 minutes. Thus, representing an innovative and successful approach contributing to the establishment of suitable QC workflows in AAV development and manufacturing.

Participants will learn about

In this webinar, researchers from ExcellGene will highlight the critical role of assay design and development - to determine - correct binding kinetics, affinity values or analyte concentrations. The optimization and evaluation of an AAV titer assay will be discussed.

Who should attend:

• Bioprocess scientists
• Scientists in analytical laboratories and QC laboratories
• Biotech researchers and people in early discovery of biotherapeutics/gene therapies and pharma development in general