Transition from manual to automated processes for autologous T cell therapy manufacturing using bioreactor with expandable culture area

Abstract Transition from the manual processes that are performed during the initial research and development (R&D) stage to automated processes for later and commercial stage cell therapy manufacturing can be challenging. It often requires significant effort, time, and costs – which hinders the...

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Main Authors: Jia Sheng Zach Lee, Akshaya V. Prabhu, Ying Ying Wu, Ahmad Amirul bin Abdul Rahim, Sixun Chen, May Win Naing, Dan Liu
Format: Article
Language:English
Published: Nature Portfolio 2025-05-01
Series:Scientific Reports
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Online Access:https://doi.org/10.1038/s41598-025-00015-4
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Summary:Abstract Transition from the manual processes that are performed during the initial research and development (R&D) stage to automated processes for later and commercial stage cell therapy manufacturing can be challenging. It often requires significant effort, time, and costs – which hinders the therapy’s access to the clinic. To ease this transition, we have developed a novel and flexible manufacturing platform, Bioreactor with Expandable Culture Area (BECA), that aims to support both R&D and manufacturing to accelerate cell therapies from bench to bedside. This report introduces two models in this manufacturing platform: BECA-S for manual small-scale operation at R&D phase and BECA-Auto for functionally closed and automated scaled-out operation at manufacturing phase. We employed these two models to streamline transition of the T cell culture process from manual to automated and reported insignificant differences in the culture outcome between the two. Our work represents the first detailed development and demonstration of a standalone cell manufacturing platform that facilitates a seamless transition between manual and automated processing for autologous T cell therapy manufacturing.
ISSN:2045-2322