Dark Horse Consulting’s Nate Manley and Sam Blackford coauthored this publication on the subject of “Expanding the analytical toolbox to address complex cell-based therapies” with Cell & Gene Therapy Insights 2022; 8(10), 1355–1369; DOI: 10.18609/cgti.2022.197.
Today’s innovators of cell-based therapies are working with increasingly complex technology platforms to develop treatment strategies that are more precisely controlled and address broader patient populations. Such innovations are built upon an increased understanding of disease pathophysiology that helps to identify the cellular and molecular players that underlie disease progression and drive recovery. Moreover, the emergence of improved ex vivo engineering strategies has enabled production of specific cell types with targeted or enhanced functional attributes. While these scientific and technological advances are empowering the next generation of cell-based therapies, they also demand more comprehensive analytical testing strategies to ensure product efficacy and safety.
This article explores the current analytical testing landscape for cell-based therapies, highlighting key analytical objectives, challenges, and emerging strategies. Analytical objectives discussed in this article include characterization of product identity and potency as indicators of efficacy, and key measures of product safety, such as monitoring for cellular impurities and genome integrity. In the context of these analytical objectives, challenges and current mitigation strategies that are specific to autologous versus allogeneic cell-based products are described. Finally, emerging analytical methods that stand poised to disrupt existing industry standards in analytical testing and address remaining challenges are considered.
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