Biophysical Critical Quality Attributes (CQAs) for Cell Therapy Products

One of the critical challenges in cell therapy is the lack of reliable, specific, and non-destructive quality attributes, which are sorely needed for all aspects of the biomanufacturing of these cells, including donor selection, in-process quality monitoring, and release testing. Most biological and biochemical assays are destructive or perturbative, which limits their utility, especially for autologous cell therapy. In this talk, I will showcase some of the emerging ideas of label-free, biophysical critical quality attributes (CQAs) we have been working on, including magnetic, electrical, and mechanical signatures of cells. Once a strong correlation with biochemical cell phenotypes is established, these will serve an important role in improving the overall production of both allogeneic and autologous cell therapy products.