Resources Core

University Of Texas Med Br Galveston, Galveston TX

Investigators

Linked publications & trials

Abstract

RESOURCES CORE ABSTRACT The Resources Core will be the “trusted provider” part of the proposed Translational Center for Microphysiological Systems-Based Drug Development Tools for Pregnancy and Women's Health. The vision of the Center is to overcome existing limitations and challenges in pre-clinical and clinical testing of drug candidates for pregnant women. The goal of the Resources Core is to provide high-quality MPS devices and cells to the Qualification Core so that the Qualification Core can successfully conduct drug testing that can lead to qualifying the MPS devices, with the ultimate goal of facilitating widespread use of the MPS devices as drug development tools for pregnancy and women’s health. The microfabrication part of the Core will be at Texas A&M University, whereas the cell part of the Core will be at UTMB. The two laboratories have been working together for the past 5+ years in developing the five feto-maternal organ MPS devices to be used here, namely the chorio-decidual interface (CD-OOC), the placental-endothelial interface (PLA-OOC), the decidual-Fetal membrane interface (FMi-OOC), the multi-organ feto-maternal interface (FMi-PLA-OOC), and the vagina-cervix-decidua interface (VCD-OOC). All cell lines, mostly derived from primary cells, have also been established and well validated. The two laboratories have already been exchanging all MPS devices as well as cells, along with usage protocols, thus are well experienced in providing the needed devices and cells mutually. Importantly, the two laboratories have also provided the MPS devices and cells to the Rusyn Lab that is leading the Qualification Core. Thus, all parties involved in the Center are already working together closely and collaborating. The Core’s work will be organized around three Specific Aims. First, the Core will microfabricate and prepare the MPS systems in sufficient quantities for the Qualification Core to conduct drug testing. Second, the Core will provide enough authenticated cells to the Qualification Core. Standard operating procedures (SOPs) for microfabrication and quality control (QC), cell maintenance, as well as MPS device operation and testing will be developed and provided as well. These SOPs will be optimized to provide MPS devices and cells that are highly reproducible with minimum device-to-device and batch-to-batch variations. Importantly, key MPS readouts from the four drugs to be tested using the MPS devices will be generated, serving as baseline data for the Qualification Core that will conduct the in-depth testing of the four drugs on the MPS devices. All MPS devices to be provided to the Qualification Core will strictly follow these SOPs, and only devices and cells that pass the QC matrix will be provided. Finally, a clear pathway towards large-scale deployment and/or commercialization of the MPS devices will be developed so that the qualified MPS devices can be provided to the broad stakeholders in a sustainable manner. The impact of this work will be contributing to multiple MPSs related to women’s health and pregnancy to be qualified for various contexts of use, especially for drug testing, and can increase the confidence for MPS devices to replace unreliable animal or single culture models.