High-throughput 3D on-chip potency assay for cell therapy products
Author(s)
Schneider, Rebecca S.
Advisor(s)
Editor(s)
Collections
Supplementary to:
Permanent Link
Abstract
Cell therapies offer promising strategies to treat diverse oncologic, inflammatory, and immune applications. Despite promising early phase clinical data, cell therapy candidates face new translational challenges, in part, due to a poor understanding of the cell therapy product during drug development and scale up. Current potency testing is often overly simplified and strongly biased by traditional 2D culture techniques. By engineering improved, well-defined, physiological-relevant in vitro systems, we aim to provide high-throughput and reproducible potency assays with improved outcome prediction of in vivo and/or clinical response. We have demonstrated proof-of-concept of the on-chip platform by showing improved in vitro immunomodulatory prediction and stronger fidelity to in vivo secretion compared to traditional 2D culture for n=9 mesenchymal stem/stromal cell (MSC) donors. We have further evaluated n=46 MSC and MSC-derivative clinical samples using the on-chip platform and found secretion outcomes with greater correlation and/or variance across donor-matched characteristics compared to 2D culture secretion. Future work will include platform clinical validation by evaluation of on-chip secretion correlation to patient-matched outcomes. The data presented here is in strong support of the value of the on-chip system to deliver scalable and high throughput cell product secretion information more predictive of in vivo and/or clinical settings.
Sponsor
Date
2023-03-14
Extent
Resource Type
Text
Resource Subtype
Dissertation