Is continuous, real-time analysis of biologics during manufacturing on its way?
William Aryitey |
Applying quality control to living organisms is tricky at best – but also crucial: the quality of biopharmaceuticals has a clear impact on both safety and efficacy. And so quality assurance is typically conducted at the end of the (lengthy and costly) biomanufacturing process – but is that logical? “If the manufacturing system produces low-quality or abnormal biologics, it is hard to see whether the product quality and system operation are normal or not during the manufacturing process through conventional analytics systems,” says Sunghee Ko, Postdoctoral Associate of Jongyoon Han’s laboratory at the Massachusetts Institute of Technology. “Because of this, current quality measurements (for example, release analytics) can lead to money loss and a disruption of biologic supplies when manufacturing has problems.”
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