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Open Insulin: biohackers trying to create a “microbrewery” for insulin as an answer to price-gouging

The Open Insulin project ("a team of Bay Area biohackers working on newer, simpler, less expensive ways to make insulin") is trying to create an open source hardware system for making insulin in small batches, through a process that uses engineered yeast to "produce a modified proinsulin protein, and an enzyme to convert the modified proinsulin into insulin glargine" so that insulin co-ops can produce and test their own insulin for a cost "from ten thousand to a few tens of thousands of dollars." The project is organized under Counter Culture Labs, a 501(c)3 nonprofit, making donations to it tax-deductible (I gave $50). Price-gouging on insulin is literally killing Americans with diabetes, while Canadians pay only 10% of what their US cousins pay. A September, 2018 article in Cell does a good job of laying out the legal and technical challenges to microbrewing your own insulin.
Open Hardware Production Platform. The process technology to make insulin and other biopharmaceuticals at a small scale should be straightforward to develop and capable of efficient production. Initial, fairly crude estimates suggest that we can build a highly automated system that integrates a bioreactor, a purification and formulation system, and QA tests in a platform that would fit in the space of a large table or the corner of a room and cost from ten thousand to a few tens of thousands of dollars. It could have a capacity from a few tens to about a hundred liters of culture, and based on typical yields obtained in industry, one such system could produce enough insulin for a few tens to a hundred thousand people. This would enable a “microbrewery” model of production ― instead of, or in addition to, only a few colossal factories in the world, there could be a few dozen or a few hundred in every city, and insulin could be produced much closer to where it is needed, which would give access to it to people who live in areas that currently lack the infrastructure for it to be transported to them. This could also make the supply chain safer by making it easier to track, contain, and recall and replace any bad batches that are produced, as Gallegos and Peccoud noted in their recent piece on the Discover Magazine blogs. It turns out that operating at a large scale produces much worse problems than it solves for production of medicine, and small scale production makes the most sense from economic and safety perspectives as well as those of access and choice. Our ideas about the open hardware platform recently received an enthusiastic reception at MIT's Global Community Biosummit, and among many other potential collaborators, Africa OSH emerged in support (our current colleague Thomas is a leader of this project as well).

New Frontiers for the New Year [Anthony Di Franco/Open Insulin] (Thanks, Mike!)

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