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

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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