Although many people could benefit from cell therapy, many can’t get it. “The entire industry is focused on ensuring safety while increasing accessibility,” says Evan Zynda, PhD, senior staff scientist at Thermo Fisher Scientific. “When it comes to developing and manufacturing cell therapies, the main challenges to these goals are manufacturing inefficiencies, complex and manual processes that require human intervention and introduce failure modes, and a lack of standardized workflows for manufacturing, especially as emerging modalities are still being defined.”
In fact, making a cell therapy is extremely complicated. “We estimate the cell therapy–manufacturing process may have upwards of 40 process steps, which is not only labor intensive but creates opportunities for errors and contamination that lead to failures,” Zynda says. “By aseptically closing and automating the manufacturing process, we’re reducing the need for the highly specialized labor required to produce these therapies, thereby eliminating touchpoints, reducing expenses, and ultimately increasing the reproducibility and predictability of the process.”
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