SMART CAMP has launched and is actively building our research team!
Label-free critical quality attributes for personalized efficacy of cell therapies, including multivariate analysis of biological and biophysical attributes.
For regulatory approval and clinical use, cell therapies must be demonstrated as both safe and effective. While this expectation of manufacturing standards seems obvious based on Phase I-IV clinical trials for a range of pharmaceutical products and medical devices, for most emerging and approved cell therapies it still remains challenging to relate therapeutic efficacy (in the animal or human patient) to the properties of the cells themselves.
FP1 addresses and identifies CQAs that (i) correlate with therapeutic efficacy and that (ii) are amenable to intermittent or inline monitoring of the therapeutic dose because the CQA measurement does not label, tag, or detectably alter the cells’ therapeutic efficacy. While these CQAs will be specific to a given cell type/source and its intended target indication (disease or injury repair), the general framework of cell population measurement (even at single cell resolution), multivariate data analytics, and validated correlation among biological, biophysical, and therapeutic outcome data is shared. Thus, FP1 will develop and demonstrate this CQA approach for multiple distinct cell types that provide contrast in technical requirements and synergies in CQA validation methodology development, including relatively surface-adherent cells such as mesenchymal stromal/stem cells and relatively non-adherent cells such as T cells.