Counter Culture Labs in Oakland is a science-oriented community hackerspace, with a focus on biohacking. In one project taking place at the lab, members are engineering yeast to express milk proteins from non-animal sources - next generation of vegan cheeses and milk. Others are busy developing an eco-friendly bacterial sunscreen.
Open Insulin is one of these projects, and its goal is to make it simpler and less expensive to make insulin, starting by investigating some novel ideas for making insulin in e. coli using fewer, easier steps than in common industrial protocols. If successful, the members hope it can be a step towards making generic production more economical, and might also enable more participation in research related to insulin, or production of the medicine at smaller scale, closer to the patients who need it, further reducing costs and giving access to more patients who lack it.
Counter Culture Labs was founded by a group of hackers with diverse backgrounds and interests in the period from 2011 to 2012, with some members coming from Sudo Room, another hackerspace in Oakland that I participated in founding. Many were also involved in Occupy Oakland, and wanted to establish a more permanent organization with the same community spirit and values. Other members came from Biocurious, another biohacking space in Sunnyvale, in the southern end of the Bay Area. I became involved both because I shared the desire to build a community-focused institution, and because I have diabetes type 1 myself, which means I live with the frustration of costly and tedious treatment regimens day in and day out, and I know how much the standard of care for diabetes patients lags behind what recent research suggests might be possible. So, for my own sake, and for the sake of the others with the condition, I sought to take whatever steps I could to close the gap between the research and what is available to patients on the market right now.
About a year ago, some long-standing discussions around making a bioreactor to produce insulin, which had inspired a few previous attempts, turned more concrete when Isaac Yonemoto, another independent researcher of medical treatments, made some suggestions to us about interesting possibilities for innovation and improvement in existing protocols. We started organising regular meetings, and out of those we then organized a successful crowdfunding campaign, which then opened up connections to professionals who work on various aspects of the problem, both the science and engineering around insulin, and the questions of access to medicine. Through this it came to our attention that access to insulin lags far behind the need even now, and even in the most developed countries - costs of insulin are prohibitive even to many people in the US - and all in all, roughly 50% of those in the world who require it have no access to insulin at all, according to the 100 Campaign, a group working on improving access to insulin around the world. There is almost no generic insulin on the American market at the moment - the first one appeared on the market about two weeks after we finished our crowdfunding campaign last year, but it is a long acting type, which is only part of the therapy required by people with diabetes type 1 (about 15-20% of diabetics in USA have type 1; the rest have type 2). And for those who use an insulin pump, short acting insulin is necessary.
The general problem in the first world is that the incentives and interests of producers and patient communities are not aligned.
Right now we’re focused on achieving the first scientific milestones, which is to produce proinsulin, the precursor of the active form of insulin, in e. coli, in our small-scale community lab. Our lab runs mostly on donated and salvaged equipment and reagents and might be comparable in its capabilities to a lab in a less-developed area of the world where there is the least access to insulin. If we succeed, it would show the possibility that small-scale producers in remote areas might be able to make insulin to satisfy local demand, in places where centrally-manufactured supplies can’t reach due to lack of infrastructure - where what roads there are, if any, do not let refrigerated trucks pass to ship needed pharmaceuticals in. Once we have a protocol that embraces everything from production to purification to near the level of purity of pharmaceutical grade insulin, we plan to approach established generics manufacturers with a case for the economic feasibility of serving the unserved market for insulin, and to partner with them to do the rest of the work of achieving sufficient purity of the product and scaling the methods to production. As we proceed with our work, the main batch of patents around the various forms of insulin are expiring, which will further help us make the case for a comprehensive portfolio of treatments to potential generics manufacturers.
Provided all this goes well, we might then pursue another idea, closer to our original hope of a bioreactor that produces insulin, and a kind of ‘holy grail’ goal in the DIY bio world, which is a desktop biofactory, an analog of desktop 3D printers, but for proteins and biologics, which we might develop to first execute one of our protocols to produce insulin, but which we might also design with more flexibility in mind. This would consist of a bioreactor portion that could grow a culture of e. coli or yeast, and then extract and purify a product from it - very roughly speaking, the union of a fermenter with an FPLC, a piece of equipment that purifies proteins. If that is possible, supply of insulin could be placed very close to the demand of the diabetics around the world in a simple, economical package, and reliance on distribution infrastructure would be minimized. It would also reduce the need to have skilled technicians with years of lab experience to execute these protocols by hand.
Ultimately, I hope that opening up the tools for research to more people can help to bring research on cures to patients, and not just treatments. Let me mention a few of the more promising ideas that have had some success in research settings. One approach is to implant functioning pancreatic cells from a donor and protect them from immune attack by various means - hard to scale if you need a constant supply of donors,but it might be possible to grow cultures of the cells in vitro to address this. Another approach is to get the immune system to cease its attack on pancreatic cells, and promote the regrowth of the body’s own insulin-producing cells, either in the pancreas, or in another tissue via gene therapy - a simpler approach to apply once it is developed. Some of the ideas use very inexpensive supplies such as adjuvants, the materials in vaccines that provoke an immune response - and there has been some success using adjuvants alone, or with carefully chosen additions, to get the bodies of diabetic patients to reduce or cease their autoimmune attacks. Other concepts address the metabolic changes behind type 2 diabetes. Several drugs between the research and commercial worlds of medicine can act directly on the metabolic control mechanisms of the body, changing its pattern of energy use and other aspects of metabolism back from the pathological state of metabolic syndrome and type 2 diabetes to the normal, healthy base state. Some of them are small organic molecules, easier to make than proteins such as insulin, but due in part to reasons of cost and incumbency, are not mainstream treatments yet.
At the most general level, what we seek to prove is that if an order of magnitude more people get involved in research and development of science and technology, medicine can progress much faster, and might no longer be held back by institutional constraints and perverse incentives in the economics of the institutions. Right now, we’re a group about half a dozen people working regularly on the project, with a few dozen more people in touch every now and then to help out, and a hundred or two in the extended community, ready to answer a question or call for help. Every week or two, someone new comes to the group, who just learned about the project via the media or our regular meetups, and wants to help. Some are complete beginners and end up taking our introductory classes to biohacking, some already have experience but got tired of the limits of the institutions where they worked, or have relatives with diabetes and want to contribute to progress. Though we’re building up a broader community of participation in research slowly, we hope our efforts can plant many seeds out of which future innovations will grow.
Meanwhile, we are looking to broaden a circle of people who can advise us, experienced scientists and engineers who can help us troubleshoot issues that inevitably come up when investigating the unknown, but we also hope to inspire other groups to work independently in a broader community of innovation. We would like to set up a network of both institutional and DIY researchers living all around the world who have different approaches and ways of making insulin as well as tackling other diabetes and health related issues. Beyond producing drugs, participants might research questions of access to medicine, investigate what patient communities need the most, look at academic publications to identify the most promising research that is not making it out to serve patients, or help establish the effort to build the desktop biofactory. Part of our goal is to prove it’s possible and worthwhile for people outside institutions to take the initiative on these questions, and inspire others to take the lead in their own efforts and bring about the broader changes we seek.
Do you have any projects in health, medicine, or biohacking that you’d like to work on, but lack people, knowledge, or resources to make it happen? Are you working on a diabetes-related solution? Or do you feel like a network of care biohackers is something you’d like to get involved with? Leave a comment and let us know.