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New Process Would Add Agility, Speed to Drug Manufacturing Process
J. Christopher Love might not be a household name at the moment, but he may become one. If not a household name, then at least a name in the pharmaceuticals manufacturing business. As Stat reports, Love has big plans.
Love, a professor of chemical engineering at MIT, wants to change the way drugs are manufactured, making it a desktop operation. A study published in Nature Biotechnology shows that Love’s new process –– Integrated Scalable Cyto-Technology (InSCyT) –– is capable of producing thousands of doses of clinical-quality biologically based drugs in a matter of days.
The study notes that past attempts at small-scale manufacturing were limited in terms of process reproducibility and product quality. This was due to their complicated methods of expressing and purifying protein.
Protein-based drugs are conventionally manufactured through the use of hamster ovary cells. Love uses the yeast species Pichia pastoris, which reduces the amount of impurities and therefore allows for a simpler purification process.
As Stat puts it, InSCyT machines would be “fast and nimble enough to help combat a small disease outbreak, treat an unusual cancer, or replace a rare enzyme.” Love’s study showed that the machines could manufacture the antiviral drug interferon alfa-2b, a human growth hormone and granulocyte colony-stimulating factor, which boosts white blood cell counts in cancer patients.
Stat paraphrases Huub Schellekens, a professor of pharmaceutical biotechnology at Utrecht University in the Netherlands, who believes that hospitals using these machines could produce drugs as needed, thereby cutting out the pharmaceutical industry’s middlemen and bringing costs down.
Schellekens and his colleagues have been doing a crude version of this process by bringing raw materials to hospital pharmacies to make drugs on site. He tells Stat: “It was apparent that if we want to really achieve this, we need hardware that is available to produce drugs on demand in a bedside situation. That is what Chris Love achieved.”
Dean Pettit, the chief scientific officer at Just Biotherapeutics in Seattle, doesn’t think that InSCyT will be able to compete with big drug manufacturers, but could be used in an emergency such as the one that occurred in West Africa with the 2014 Ebola outbreak. In that case, not enough vaccine reached everyone who needed it in time. “In a case like that,” Stat reports, “a few InSCyT machines could potentially be shipped to hospitals treating patients, and rapidly directed to make the vaccine.”