Historically, automated CGT systems had limited real-time monitoring capabilities, instead relying on manual sampling and analysis of CPPs and CQAs by the operators. The difficulty of integrating sensors designed for much larger bioreactors, limited standardization of hardware and software, and the lack of robust measurement technologies, are partially to blame.
Without the ability to monitor critical parameters in real-time, operators must rely on periodic manual sampling and off-line analysis for tracking cell culture conditions and making process adjustments. This is costly, labor-intensive, consumes valuable material and can increase the risk of process contamination.
However, the recent integration of automated CGT manufacturing systems with real-time monitoring technologies represents a transformative approach to cell and gene therapy manufacturing. This combination addresses critical challenges in cell expansion, offering improved scalability, reproducibility, and tighter process control.
As the field of cell and gene therapy evolves, these innovations will play a pivotal role in shaping the future of therapeutic development and manufacturing, enhancing the efficiency of current processes and paving the way for next-generation therapies available to a broader population.
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This article was originally published in American Pharmaceutical Review.
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