Open Insulin Project
By Ruby Irene Pratka:
" Insulin is one of fewer and fewer drugs for which no generic version is available. According to an NPR report from 2015, as these more expensive, new drugs became available, the older ones left the market. The bill for uninsured patients can be several hundred dollars per month — as a result, one Baltimore doctor told NPR that some of his patients had stopped taking the drug altogether, putting their health at risk.
Anthony DiFranco and his team at Oakland's Counter Culture Labs are hoping to change that. DiFranco is a medical researcher, self-described bio-hacker, and cofounder of the Open Insulin Project. He has Type 1 diabetes himself. DiFranco and his team are working on a protocol to extract insulin from genetically engineered yeast cells and produce a generic drug at a cost of around $10 for a month's supply. He says users could even eventually produce the drug in their homes. The project has created a definite buzz, raising nearly $17,000 in a crowdfunding campaign on the science-oriented crowdfunding platform Experiment." (https://www.shareable.net/blog/how-biohackers-at-counter-culture-labs-are-trying-to-make-insulin-more-affordable)
From an interview of f Anthony Di Franco by Ruby Irene Pratka:
* "Considering that close to 30 million people in the US alone live with this disease, you would think someone would have tried this before now. Why haven’t they?
I can only speculate on the reason, but it's undoubtedly a lot of work. Many people seem to be afraid of having to deal with regulatory requirements that cost big companies millions. Insulin is one of the last holdouts where there is no generic version of the drug after more than 90 years. There are low-cost producers in other countries, but Western producers are very good at holding onto the [domestic] market. In some cases, drug companies have paid generic manufacturers not to produce drugs. The big producers are determined to keep their oligopoly.
* Chemically, what is insulin? What are you building in the lab?
It's a very small protein. In the lab, you need to introduce a gene into some organism so it creates the protein, and then find some way to extract it. We started with a protocol to make it in E. coli bacteria, but bacteria lack the sophistication to modify or secrete proteins, so the protein we extract is proinsulin, which still needs to be modified into the active form in the lab. We were looking at just making the proinsulin and making small changes to it that would allow us to complete the other steps in vitro... Now that we have some people on board with expertise in yeast engineering, we're thinking about moving [the production] to yeast. With yeast cells, you can engineer them to secrete insulin, instead of having to extract proinsulin from dead cell debris [as with the bacteria cells]. Then you can purify [the insulin] from yeast, which is a relatively simple task. That's what we’re focusing on. We're still just making proinsulin as a first step and working on engineering the yeast to do everything for us. Our final product will be a strain of yeast cells that secretes insulin. Once we succeed, we will share what we come up with and build something that works for the long term.
* Why is it so expensive?
Markets are the main reason. It's not that expensive to produce. For me, a month's supply would cost about $10 to produce, but I’m paying about $1,000 before insurance and still $75 after insurance. If people were paying $15 for a drug that cost $10 to produce, that would still be a very healthy profit margin.
* Tell us a bit about the work that has gone into this.
Most of it was just persistence. Some weeks there was very little to do in the lab and some weeks there was much more. Right now the yeast experts are the ones that are always in the lab, and I'm doing the organizing. It has been a lot of work, and we have had quite a few people coming and going, but it's important enough to enough people that we always have enough people to keep moving it forward. A lot of our volunteers have just finished school and have the perfect science background, and they see it as doing something cool for a good cause.
* What remains to be done to get the yeast-produced insulin into circulation?
We need to compete the yeast engineering, figure out a technique for purifying it and then look at the next step — how to set up a low-cost manufacturing operation and get over all the regulatory hurdles. That would require more money and more organizational sophistication than we have now, but hopefully by then our case will speak for itself and we will be able to prove we have the technology and it is usable. It will not be a for-profit undertaking." (https://www.shareable.net/blog/how-biohackers-at-counter-culture-labs-are-trying-to-make-insulin-more-affordable)