Analytical Ultracentrifugation for Characterization of AAV Gene Delivery Vectors

BPI Contributor

December 8, 2020

20 Min View
Analytical Ultracentrifugation for Characterization of AAV Gene Delivery Vectors

Date: Dec 8, 2020

Duration: 20 Min

This webcast features: Christopher Sucato, PhD, Associate Director, Biophysical Characterization, and Cynthia Swanson, Associate Research Scientist, Charles River Laboratories

Analytical ultracentrifugation (AUC) has been a staple in the biopharmaceutical industry to analyze aggregation and higher-order structure in protein drug products. With the recent boom in cell and gene therapies using gene-delivery vectors, new avenues for AUC-based characterization and QC lot release methodologies are now available. View this webinar for a discussion on the new parameters of AUC analysis and how to maintain conformation to ICH guidelines. Learn how to bridge the gap from traditional methods to a high-quality AUC platform for your AAV program.

In the second part of this webinar, we will discuss the Aiforia neural network (NN), which has been trained to recognize negatively stained AAV capsids in TEM images. The NN is also able to sort capsids based on the amount of stain within the structure. Electron-lucient (unstained) homogenous capsids are classified as full, those with an electron-dense core (stained) are classified as empty, and capsids containing a non-homogeneous staining pattern are classified as intermediate. This sorting of empty, full, and intermediate capsids in the image allows for the ratio to be estimated for a given sample.

During this webinar, learn how:

  • AUC can meet the characterization needs for AAV products

  • AUC can be validated for AAV products – precision, linearity, limit of detection, and accuracy

  • TEM can be used for AAV capsid sorting.

Watch the recorded webcast now.

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