Dark Horse Consulting’s Sean O’Farrell recently published “Harnessing the power of design of experiments for cell therapy research & process development” with Cell & Gene Therapy Insights 2022; 8(11), 1487–1495. DOI: 10.18609/cgti.2022.217
The complexity and cost of producing cell therapies, coupled with their promising clinical potential, equates to a need for comprehensive process understanding and optimization so that high-quality drug product can be delivered to patients amidst challenging timelines and increasing regulatory demands. Design of experiments is a compelling component of the process analytical technologies tool kit, which when used in a controlled experimental framework, allows for assessment of how multiple factors drive a defined set of outcomes, thereby enabling (i) improved cell therapy process understanding and/or (ii) robust and reproducible cell production process optimization. In this article, some of the key considerations for best practices for DoE in cell therapy research and process development are highlighted. Moreover, the application of DoE approaches in cell therapy is likely to require customization to support the intricacy of such experiments and allow for reliable modeling of these.
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