Development and Implementation of Organ-on-a-Chip Devices for Replacing Traditional Preclinical Assays

Abstract

The proposal focuses on developing and implementing organ-on-a-chip devices as an innovative solution for conducting preclinical, safety, and efficacy assays. These are crucial steps in researching and developing new products within the pharmaceutical and cosmetics industries. The relevance of this technological solution is tied to the challenges these sectors face in ensuring their products reach the end consumer safely and with proven efficacy. The pharmaceutical industry, in particular, has experienced a notable decrease in the number of drugs approved by regulatory bodies in recent decades. This trend is due to false positive and negative results obtained during preclinical phases. The in vitro assays currently applied fail to replicate human physiological interactions, significantly contributing to efficacy failures in later stages. While animal models mitigate these in vitro assay issues, ethical limitations and physiological differences can compromise the applicability of animal model results to humans. This challenge is heightened in the cosmetics sector by Brazilian Senate Resolution No. 58, approved on February 24, 2023, which prohibits the use of animal models in specific contexts. Microphysiological systems, such as organ-on-a-chip, are attractive solutions to address these gaps. These microfluidic devices are designed to simulate the body's physiological functions more accurately, mimicking specific human organ characteristics. This approach significantly improves the precision of safety and efficacy evaluations of compounds under study while reducing the costs associated with these assays, accelerating innovation, and developing new products. (AU)