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Updated: Oct 29, 2025

Fabrication of a Multiplexed Artificial Cellular MicroEnvironment Array
Published on: September 7, 2018
Engineering microenvironments for manufacturing therapeutic cells
1Division of Cellular and Gene Therapies, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20903, USA.
Abstract:
There are a growing number of globally approved products and clinical trials utilizing autologous and allogeneic therapeutic cells for applications in regenerative medicine and immunotherapies. However, there is a need to develop rapid and cost-effective methods for manufacturing therapeutically effective cells. Furthermore, the resulting manufactured cells may exhibit heterogeneities that result in mixed therapeutic outcomes. Engineering approaches that can provide distinct microenvironmental cues to these cells may be able to enhance the growth and characterization of these cell products. This mini-review describes strategies to potentially enhance the expansion of therapeutic cells with biomaterials and bioreactors, as well as to characterize the cell products with microphysiological systems. These systems can provide distinct cues to maintain the quality attributes of the cells and evaluate their function in physiologically relevant conditions.

