Automated Cell Processing Platform for Early Research and Development of Cell Therapies - Project Summary/Abstract The University of Florida (UF) requests support for the acquisition of the Miltenyi CliniMACS Prodigy, a closed, automated cell processing platform that integrates cell selection, activation, genetic modification, expansion, and formulation into a single instrument. The Prodigy will be installed in UF’s Good Manufacturing Practice (GMP) Facility, a shared institutional core that supports NIH-funded investigators developing cellular immunotherapies, regenerative medicine approaches, and gene-modified cell therapies. Current workflows in the GMP Facility rely on manual, labor-intensive processes that are inefficient, variable, and capacity-limiting. These manual methods also pose a major limitation in translating early research protocols into compliant clinical manufacturing, as they introduce variability and lack robust process control. The CliniMACS Prodigy addresses these limitations by providing end-to-end automation, reducing hands-on operator time, minimizing variability, and establishing reproducible, GMP-ready workflows. By enabling seamless transition from preclinical development to clinical-grade manufacturing, the Prodigy derisks process control and accelerates translation. The instrument will immediately benefit multiple NIH-funded projects in pediatric and adult cancer immunotherapy, regenerative stem cell therapy, and gene-modified cell therapy. It will support the generation of CAR-T cells, tumor-infiltrating lymphocytes, hematopoietic stem cells, and dendritic cell vaccines, thereby accelerating the translation of laboratory discoveries into early-phase clinical trials and enabling mechanistic studies of immune responses and tumor microenvironment interactions. The long-term objective of this request is to establish UF as a regional leader in advanced therapy manufacturing by providing access to state-of-the-art, automated cell processing. This shared resource will expand capacity for multi-user projects, foster cross-disciplinary collaborations, and build a skilled workforce trained in GMP-compatible automation. Ultimately, the Prodigy will catalyze innovation, sustain institutional competitiveness, and accelerate the development of novel immune-based therapies that improve public health.
