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Researchers use this microchip to search for cells that can produce proteins most prolifically.

He and other researchers hope to change that by making biomanufacturing more predictable. One of Love’s goals is to make sure the cells that produce these expensive drugs are as productive as possible, which should bring costs down. To do that, researchers take advantage of the natural differences in productivity among cells. They foster mutations to create genetic variability and then use microchips to analyze the behavior of individual cells, choosing the most prolific for larger-scale production.

A second major challenge in biomanufacturing is ensuring the quality of the drugs, which is complicated because protein-based drugs must fold into a three-dimensional shape and must have the appropriate chemical tags. And because these drugs are produced under conditions favorable to microbes, they can be infected with viruses. “Many mistakes are made because we don’t have the right analytics to measure the product or process,” says Cooney. “Manufacturing sits on a critical path between science and the patient and should be integrated into the continuum of drug development. I think most companies know they need to invest early on in manufacturing, but they don’t put enough effort into process development early on.”

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Credits: Conrad Warre/TR

Tagged: Business, Business Impact, Advanced Manufacturing

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