SEP 03, 2020 9:00 AM PDT

The Complexities of SV Analytical Ultracentrifugation: AAVs are not Simple, Binary Systems

Speaker
  • Founder and President, BioAnalysis, LLC
    Biography

      Lake Paul began his education at the University of Miami with a major in Biology, Chemistry and Religious Studies. Soon after, he moved for doctoral studies in Structural Biology and Biophysics at Purdue University. While at Purdue, Dr. Paul was a Ruth L. Kirschstein Pre-Doctoral Fellow, Howard Hughes Biomedical Scholar and Fredrick Andrews Fellow. After Purdue, he worked as a post-doctoral fellow with NIEHS in Raleigh-Durham studying the development of mass spectrometric techniques for easier identification of crosslinked products. Epitope mapping of the HCV E2 glycoprotein using mass spectrometry. From there, he returned to Purdue University as the Director of the Biophysics Analysis Lab and the Purdue Proteomics Facility. Dr. Paul moved back into industry when he joined Triclinic Labs, Inc and later Abzena where he further crafted his skills in method development and validation, patent submissions, commercialization, discovery/process development, cGMP manufacturing and cGMP bioanalytics. In 2019, Dr. Paul founded an innovative and dynamic CRO/consultancy company, BioAnalysis, LLC. This collaborative CRO has expertise in the areas of analytical method development, GMP validation, CMC strategy and quality control. The company also specializes in the areas of Biophysics and Mass Spectrometry applications for mAbs, Therapeutic Proteins, Gene Therapy, ADC and Nanoparticles. With over 27 peer reviewed publications, BLA/MAA submissions and FDA/EMA responses, BioAnalysis, LLC provides a unique, personalized and agile service to small and large pharma companies.


    Abstract

    DATE:  September 3, 2020

    TIME:   09:00am PT, 12:00pm ET

     

    As SV-AUC becomes the go-to method for quantitation and characterization of AAV, caution must be taken during the experimental design and analysis. The heterogeneous nature of the intermediate capsids, possible self-associations, pressure effect of the hydrodynamic shape of the capsids, and even the approach to the data fitting are factors that must be carefully considered. A complete and robust understanding of the aforementioned factors along with a strong experimental design can produce reliable SV-AUC methods suitable for cGMP qualification and beyond.

     

    Learning Objectives:

    • Identify approaches to correctly analyzing AAV systems.

    • Applying Analytical Ultracentrifugation (AUC) in a cGMP environment

    • Develop proper experimental design for AAV systems and extracting the correct information.

     

     

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