NOV 04, 2020 11:00 AM PST

Developing flow-based analytical methods for gene-edited CAR-T programs: How to ensure an efficient transition from early research to clinical development

Sponsored by: Miltenyi Biotec
C.E. Credits: P.A.C.E. CE Florida CE
Speaker
  • Scientist, CAR-T In Vitro Biology Lead; Beam Therapeutics
    Biography

      Aaron received his Masters in Biomedical Sciences from Boston University in 2014, where he worked at the Ragon Institute of MGH, MIT, and Harvard to help develop mRNA vaccines to allow for the production of functionally enhanced antibodies targeting various pathogens. After graduating, he continued his work with this technology at Novartis Vaccines and Diagnostics, exploring ways to improve mRNA vaccines currently under development. His interest in mRNA technologies eventually led him to Bluebird Bio, where he applied his previous learnings on the technology to both gene-edited CAR-T and tgTCR programs. He is now at Beam Therapeutics, where he is the in-vitro biology lead for their first base-edited CAR-T program.


    Abstract

    DATE:  November 4th, 2020

    TIME:   11:00am PST

     

    As cell therapies become more complex, the need for robust analytical tools to characterize such products as they enter the clinic has increased in kind, especially those related to flow cytometry. CAR-T therapies are no exception to this trend, with the next generation of products containing multiple binders, synthetic receptor/ligand combinations, and/or numerous genetic edits. These additional product accoutrement introduce challenges to the already required FACS-based purity, identity, and safety assays needed to begin clinical trials. To ensure a streamlined transition from early research all the way through clinical development, the latter of which is oftentimes performed at external CDMOs, it is critical to establish analytical assays and streamlined processes utilizing machines that can ensure consistent and reproducible data not only across groups within a company but also between production sites. By creating this infrastructure early in the development of next generation cell therapeutics, scientific organization can avoid costly delays and misinterpretation of data that will ensure the most opportunities for the field to successfully take their products to the clinic, hopefully benefitting patients in need.


     
    Learning Objectives:

    • Identify key considerations for the development of flow cytometry-based methods for characterization of CAR-T cell products
    • Establish robust and reproducible results early in the development process
    • Recognize how to best prepare analytical assays for tech transfer to external organizations

     

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