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  1. Advancing Regulatory Science

Applying Additive Manufacturing for Continuous Production of Extracellular Vesicle Products

CERSI Collaborators: University of Maryland, College Park: Steven Jay, PhD; William Bentley, PhD

FDA Collaborators: Kyung Sung, PhD (Principal Investigator); Kirstie Snodderly, MS

Project Start: January 27, 2023

Regulatory Science Challenge

Extracellular vesicles (EVs) are small particles produced and released by cells that have recently emerged as potential therapies in a wide variety of diseases and injuries. The biologic origin of EVs may have an advantage in accessing parts of the human body with more ease than synthetic systems. Therefore, EV-based therapeutic products may be effective in counteracting existing (and potentially future) biological threats. For example, EVs-based therapeutic products are being developed for acute respiratory distress syndrome, burn wounds, infection, and other applications. It is challenging, however, to produce EVs at large-scale. The goal of this project is to overcome limitations associated with large-scale EV production and to provide viable solutions to meet the demand for EVs to be incorporated into biodefense and therapeutic products. Researchers plan to accomplish this goal by developing a continuous EV production process which leverages prior work on a bioreactor design that incorporates a 3D printed cell separation device for EV purification.

Project Description and Goals

Typical EV separation methods involve ultracentrifugation and/or filtration. However, these techniques are inadequate for scale up due to high cost as well as physical limitations. As an alternative, researchers aim to create a continuous EV separation process by optimizing the design of a 3D printed device that separates particles based on liquid flow through channels of specific dimensions. EV batches made with this device will be compared to EVs produced using centrifugation/filtration approaches using a battery of analytical techniques. These will include EV characterization methods as well as cellular response experiments to EVs. As a deliverable of this project, researchers aim to generate a scalable prototype system for continuous EV production.

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