J. Ling, N. McMahon, K. Zimmern, H. Easterling, R. Zamilpa
Southwest Research Institute,
Keywords: Biopharma manufacturing platform
Summary:Currently, there is a lack of suitable manufacturing platform for the expansion of large number of stem cells and other anchorage-dependent cells needed in cell-based therapies and engineered tissue fabrications. Existing cell culture systems are either limited in scalability, have a significantly different culture environment from the traditional 2D culture, or difficult to harvest single-cells suspensions. Cell manufacturing using the traditional 2D culture platform like T-flasks, roller bottles, or CellFactory systems is an expensive, labor-intensive cell culture process, and typically requires a high-cost ISO 5 cleanroom environment. Southwest Research Institute (SwRI) has developed a novel cell manufacturing platform to propagate cells using a 3D printed, single-use, and scalable bioreactor (Figure 1) in a perfusion-based closed cell culture system (US 10,988,724 B2, 2021).This bioreactor system has the unique features of 1) mimicking 2D culture but offering scalable culture surfaces/capacities, 2) providing a low-shear cell culture environment, 3) facilitating automation through perfusion-based media/oxygen delivery, 4) easy scaling up, down, and out while maintaining cell culture process.