Improving bioprocessing with process analytical technology (PAT) is not a new idea, but it’s still in need of technology that makes it possible. In 2004, the FDA described PAT as a regulatory framework that will “encourage the voluntary development and implementation of innovative pharmaceutical development, manufacturing, and quality assurance.” In 2018, Roche scientists noted: “If PAT is effectively applied to bioprocesses, this can increase process understanding and control, and mitigate the risk from substandard drug products to both manufacturer and patient.”
In the United Kingdom, scientists at Microsaic Systems envisioned putting PAT in bioprocessing with real-time mass spectrometry (MS), and now the company claims success.
For years, Microsaic worked on getting MS in places where bioprocessing needs it. That’s why the company calls it point-of-need MS. Now, through a collaboration with the U.K.-based Centre for Process Innovation (CPI), Microsaic claims that its micro-engineered MS can be connected directly to an autosampler on a bioprocessing line to provide real-time analysis. Microsaic’s technology is small, which is key to getting MS anywhere near a bioprocessing line. Despite the platform’s small size, it can detect small and large molecules, up to 3,200 m/z.
Given the potential value of getting analytical tools on bioprocessing lines, it’s no surprise that CPI and Microsaic Systems are not the only ones working on it. Plus, it’s not all about MS. For instance, one team of scientists described optoelectronic noses for analyzing bioprocessing.
To make an industry-wide move to bioprocessing 4.0, real-time analysis needs to get closer to the manufacturing line. That could come from miniaturized MS plus the accessories that make the connection or something entirely unexpected.