Large‐scale, reproducible manufacturing of therapeutic cells with consistently high quality is vital for translation to clinically effective and widely accessible cell therapies. However, the biological and logistical complexity of manufacturing a living product, including challenges associated with their inherent variability and uncertainties of process parameters, currently make it difficult to achieve predictable cell‐product quality. Using a degradable microscaffold‐based T‐cell process, we developed an artificial intelligence (AI)‐driven experimental‐computational platform to identify a set of critical process parameters and critical quality attributes from heterogeneous, high‐dimensional, time‐dependent multiomics data, measurable during early stages of manufacturing and predictive of end‐of‐manufacturing product quality. Sequential, design‐of‐experiment‐based studies, coupled with an agnostic machine‐learning framework, were used to extract feature combinations from early in‐culture media assessment that were highly predictive of the end‐product CD4/CD8 ratio and total live CD4+ and CD8+ naïve and central memory T cells (CD63L+CCR7+). Our results demonstrate a broadly applicable platform tool to predict end‐product quality and composition from early time point in‐process measurements during therapeutic cell manufacturing.
Manufacturing is a key economic activity. Its know-how and its competitive advantages have shaped the history of humankind. In many Industrial Engineering (IE) programs, however, manufacturing is not taught as related to process know-how, but as systemic integration and management. It is possible to capitalize on the recent 3D printing technologies to reintroduce IE students to manufacturing principles through prototyping projects. Sparking the interest of IE students, though, can also be achieved through selecting problems of environmental awareness. This work describes a project of self-assemblies developed under the scheme of undergraduate research that makes prototyping a central endeavor with the aim to foster plastic recycling as an end goal.
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