Progress in developing microphysiological systems for biological product assessment.

ABSTRACT

Microphysiological systems (MPS), also known as miniaturized physiological environments, have been engineered to create and study functional tissue units capable of replicating organ-level responses in specific contexts. The MPS has the potential to provide insights about the safety, characterization, and effectiveness of medical products that are different and complementary to insights gained from traditional testing systems, which can help facilitate the transition of potential medical products from preclinical phases to clinical trials, and eventually to market. While many MPS are versatile and can be used in various applications, most of the current applications have primarily focused on drug discovery and testing. Yet, there is a limited amount of research available that demonstrates the use of MPS in assessing biological products such as cellular and gene therapies. This review paper aims to address this gap by discussing recent technical advancements in MPS and their potential for assessing biological products. We further discuss the challenges and considerations involved in successful translation of MPS into mainstream product testing.