SEP 29, 2020 7:00 AM PDT

Considerations in the Use of Analytical Ultracentrifugation for Characterization of AAV Gene Delivery Vectors

Sponsored by: Beckman Coulter
C.E. Credits: P.A.C.E. CE Florida CE
Speaker
  • Associate Director, Biophysical characterization at Charles River Laboratories.
    Biography

      Christopher Sucato is Associate Director for biophysical characterization at Charles River Laboratories. Prior to joining Charles River, as part of the acquisition of Blue Stream Laboratories, Dr. Sucato led the biophysical group at Blue Stream from 2010 to 2016. Dr. Sucato was a Ruth L. Kirschstein National Research Service Award fellow at the Departments of Biomedical Engineering and Biophysics at Boston University, where he developed nanoparticle-based agents for the early detection of biomarkers in inflammation. Dr. Sucato's research experience includes characterization of protein-protein and protein-nucleic acid interactions by a range of techniques, and the evaluation of kinetic interaction constants. Dr. Sucato holds a Ph.D. (2008) in Chemistry/Biochemistry from the University of Southern California.


    Abstract

    Date:  September 29, 2020

    Time: 7:00am PDT,  10:00am EDT

     

    Analytical Ultracentrifugation (AUC) in the biopharmaceutical industry has traditionally been employed in the analysis of aggregation and higher order structure in protein drug products. More recently, gene delivery vectors have opened new avenues for AUC-based characterization and QC lot release methodologies. We discuss here the parameters of an AUC method which conform to the objectives of an ICH/cGMP validation and suggest gap-bridging strategies to maintain a high-quality AUC platform for use in AAV programs.

     

    Learning Objectives:

    • Understand the AUC parameters used to characterize AAV gene therapy vectors.
    • Learn how AUC can help in characterization of viral vectors for lot release.
    • Learn about strategies and methods used to bring AUC in line with cGMP.

     

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