ABSTRACT The development of three-dimensional (3D) disease models has paved the way for accelerated design, discovery, and validation of potential targets and drug compounds, thereby significantly reducing the time, cost, and labor involved in the drug discovery pipeline. 3D spheroidal cell aggregate models have been established as more accurate and predictive than two-dimensional (2D) models for drug screening. However, current commercial techniques for spheroidal tissue formation rely heavily on the self-aggregation of single cells and have substantial limitations concerning production consistency, control, and flexibility. That makes VivoSphere a breakthrough product. VivoSpheres are cell-laden hydrogel microspheres that are produced rapidly using our microfluidic platform. Compared to self-aggregation systems, incorporation of hydrogel matrices in VivoSpheres can improve the consistency of tissues in size and shape, which is critical in getting high-quality results in high-throughput screening (HTS), and provide the ability to manipulate the cellular microenvironment, which is an important driver of appropriate cell phenotype and function. The cell types will no longer be limited to self-aggregating cells. Instead, there will be great flexibility in selecting either aggregating or non-aggregating cells, and even multiple cell types for co-encapsulation. This project will use cancer cells to demonstrate the high consistency of VivoSpheres as more suitable for HTS compared to self-aggregation systems, establish the ability to form VivoSpheres using non-aggregating cancer cells, and optimize key assays used in HTS. The outcome of this project will remove potential roadblocks to building disease-specific models for HTS. VivoSphere is VivoSphere LLC’s first product and is protected by non-provisional patents.

NARRATIVE For preclinical drug discovery, new in vitro models are needed to obtain more translatable study outcomes in a low-cost and high-throughput manner. The outcome of this project will be tissue engineered spheroids, or VivoSpheres, that better model human biology than current commercial products for high-throughput screening. As a platform technology, the VivoSpheres can be used for a wide range of disease and tissue modeling and generate high quality drug response data to make translational research more efficient.