In attempting to bring greater predictability to biomanufacturing processes, MIT scientists are tweaking cell productivity and tackling the complexities of biopharma quality.
"Manufacturing sits on a critical path between science and the patient and should be integrated into the continuum of drug development," says chemical engineer Chris Love, in MIT's Technology Review. Most companies know they need to invest "early on" in manufacturing, during drug development stages, he says, but they don't put enough effort into process development then.
Unlike the chemical synthesis processes behind small molecule drugs, bioprocessing uses live cells. And for every bioreactor run, "the result can be a bit different." Love aims to make sure that cells used in bioprocessing are as productive as possible--knowledge that should improve predictability. He and his team are capitalizing of the natural differences in productivity among cells. They force mutations, analyze resulting cell behavior and then use the most prolific for larger-scale production.
Their second target, ensuring biopharma quality, "is complicated because protein-based drugs must fold into a 3D shape and must have the appropriate chemical tags," the article says. In addition, the drugs are produced under conditions favorable to microbes, increasing the likelihood of viral infections. Just ask Sanofi unit Genzyme, now operating under consent decree with the FDA for just such contamination issues at its Boston-area plant in 2009.
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