Abstract
Cell therapy manufacturing workflows typically involve multiple complex steps, requiring extensive hands-on and labor-intensive interventions. They also typically involve several open processes, spanning a multitude of different products. As emerging therapeutics move through the clinical pipeline, scale and regulatory compliance have come to the forefront of the discussion. Closed, modular systems can help overcome some of the current cell therapy manufacturing challenges associated with lack of flexibility, maintenance of sterility, and a lack of standardization. A key to addressing these challenges and facilitate scalability lies in both process automation and digital automation. In this article, experts discuss how a fully automated cell therapy manufacturing process, which addresses digital connectivity and instrument-to-instrument compatibility, can increase quality of the final product and reduce manufacturing failure rates.
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