Stellium® is a proprietary microfluidic-based cell migration assay that serves as an invaluable tool for therapeutic developers to corroborate Critical Quality Attributes (CQAs) of cell-based therapy products.
Potency Test Device
“Stellium® was engineered to be the ultimate tool for developers to address regulators’ concerns on Critical Quality Attributes and assist them in the journey towards clinical-scale production of cell-based therapies.”
Juan Pablo Acevedo, Ph.D.
Director of the Tissue Engineering and Biofabrication R&D Division
Easier and faster cell migration assessment. Stellium® is a state-of-the-art cell migration device designed to comply with the guidelines from the FDA and serve as a quick system for quality control (QC) and as a tool to examine batch consistency for cell dosing in the cell therapy field. This operator-friendly tool facilitates the study of cell migration due to its versatility, higher resolution, and accelerated directed cell migration without the need for profound experience in microfluidics. The main characteristics are obtained after adapting different elements in the design, including the series of open parallel migration lanes fabricated with a non-swelling gelatin-based hydrogel and encapsulating migration factors. These features all together contribute to an effortless and more rapid migration assessment avoiding the need for continuous recording using specialized software for cell tracking.
A more standardized and informative potency assay. Stellium® has shown higher reproducibility, resolution, and robustness than other cell migration evaluation approaches, particularly the scratch and Boyden chamber assays. Stellium® gives more information about the migration capabilities of a cell sample and can adapt to technologies such as confocal microscopy and live-cell imaging. In our Lab on a Chip paper, we reported the use of parametric information extracted from the migration profiling to develop predictive models of immunosuppressive cell function that could be applied as a potency test for stem cells. The detailed profiling of migration behavior given by the new device has demonstrated a broader assay sensitivity compared to other migration assays and higher versatility in studying cell migration in different settings of applications.
Addressing FDA’s Critical Quality Attributes (CQAs) concerns. Recently, the FDA objected to a BLA submission due to CQA concerns and requested the sponsor to present “further scientific rationale to demonstrate the relationship of potency measurements to the product’s biologic activity.” The statement reflects the importance to the FDA of proving the precise relationship between quality attributes and the clinical performance of specific cell therapy lots. This response, in addition to FDA’s guidances, emphasizes the need for using assays that directly measure complex cell activity, unlike a surrogate assay based on single molecule detection or miRNA fingerprint. In this regard, the published data generated by Stellium® from the migration of stem cells, and its correlation to their fundamental therapeutic action, supports the value of using Stellium® for clinical-scale expansion in cell-based therapy settings and compliance with FDA’s Potency Test Guidance.
