What is the Open Insulin movement?
Open Insulin is an international team of volunteers seeking to correct the tragic under-supply of Human Insulin in the global market. We take inspiration from Banting, Best and Collip – scientists who saw the potential of Insulin as a miracle treatment and sold their intellectual property for $3 in 1922. Despite their philanthropic intentions, the price has remained beyond the purchasing power of over half the world for nearly a century.
Our team wishes to demonstrate top-to-bottom production of purified, native Human Insulin from E. coli for a variety of industrial scales. Our hope is that by aggregating this knowledge and freely supplying our modified E. Coli to generic manufacturers, we will be able to disrupt the Pharmaceutical Industry’s insulin oligopoly once and for all.
Timeline of Biofoundry & OI:
2016: Biofoundry Joins Project in November
2017: After many months of research and petitioning, the project is picked up by Nicholas Coleman of USYD for iGEM 2017! Together, we had a DISCO! Click the image to visit the wiki and explore all we achieved, including full protocols and gene sequences for creating an insulin-producing bacteria!
2018: Unfortunately the bacillus strains produced by DISCO had to remain
under the control of USYD, but we managed to bring back samples of the four E. coli strains as well as purified plasmid DNA. Biofoundry was a space with a lot of potential, but nowhere near the standard of the facilities at USYD. This year was defined by continual upgrades to the lab, as well as attempts to replicate protocols that we’d learnt at Coleman Labs. We were lucky enough to be invited to the 2018 Geneva Health Forum, where we presented the results of DISCO and talked about our plans for the future.
2019: Obtaining a new open source plasmid (pUS24X) from our friend Mark at Coleman Labs, the Restriction Digest, Ligation, Heat Shock, Recovery and
Miniprep of a new insulin-producing plasmid was successfully carried out.
Working within our open-source lab, with almost no funding – we were now able to produce biosynthetic organisms. While this is technically the same
achievement as in 2017, the radical reduction in cost and facility quality
marks this as a success in it’s own right. We could now turn the focus of our
lab work towards protein purification…
Meanwhile, we worked with a new Bangladeshi company to help them source an approved biosynthetic strain for insulin production, wrote and successfully sought approval for a NESA course to teach teachers and attended the Experts on Diabetes Summit in Geneva. In attendance was the Director of the WHO, who made this announcement three days later.
Oh! We also made it on the telly…
2020: We hope to achieve a high standard of protein purification in 2020, perform our own ELISA assays and continue to search for an H-PLC to help model medical-grade purification. We are excited to start teaching high school teachers about the Open Insulin project and hope to use it as a gateway to introduce Synthetic Biology into the Australian curriculum.
Why is this a problem? Why hasn’t it been fixed?
The intellectual property protecting classic Human Insulin expired in 2014, yet the ‘Patent Cliff’ that normally results from the entrance of Generics never occurred. Three companies possessed a 92% market share in 2016 – with the majority of their sales occurring within developed nations that enjoy lucrative pharmaceutical benefit schemes. There is no financial incentive to produce the older, off-patent Human Insulin as it would only undercut their valuable analogue market. Understanding the legal distinction between Human Insulin and it’s substitute Analogue Insulin is crucial to untangling the complex weaves of market control exhibited here.
What is Analogue Insulin? What benefits do these products convey?
“The evidence indicates that across Type 1 and 2 diabetes, for both rapid- and
long-acting analogue insulins, there is no clear advantage over human insulins, with inconsistent statistically significant advantages and lack of clinically important benefits. Analogue insulins have not consistently been demonstrated to be cost-effective, and uncertainty remains regarding the association between analogue insulins and increased cancer risk.”
WORLD HEALTH ORGANISATION, 2011
While this quote seems damning of Analogue Insulins, their potential to revolutionise Diabetes treatment should not be understated. Type 1 Diabetes sufferers can enjoy a normal lifestyle with standard Human Insulin, however Basal + Long-Acting analogues can significantly reduce injection frequency and incidence of Hypoglycemia. Single-chain thermostable analogues could significantly simplify shipping and storage in arid areas and more advanced insulin pump/analogue systems reduce the impact of the disease on patient lifestyle.
NONE OF THESE FACTORS EXCUSE THE PRICE OF HUMAN INSULIN. Advancement in the potential of insulin treatment will not console the 50 million people whose purchasing power precludes them from accessing this miracle drug. By keeping Human Insulin prices in lockstep with their Analogues, these three companies hold international pharmaceutical benefit schemes hostage – costing the developed world billions of dollars, and the developing world millions of lives.
Collusion or a natural result of low competition?
How can the Open Science movement fix this state of affairs?
Open Insulin – Counter Culture Labs
BioFoundry is not the first, nor last company to observe the struggle of Diabetes sufferers in low-middle income countries. Many African nations have specialised companies dedicated to improving access to Insulin, however they will face an uphill battle until someone rectifies the supply chain. Open Insulin, run by Counter Culture Labs in America were one of the first in the democratic science movement to attempt to solve this problem, raising over $16,000 from angel investors and generating a huge quantity of positive press in 2015/2016.
BioFoundry approached CCL with the offer of a collaborative partnership at the end of 2016 and we’ve been quite overwhelmed with the volunteer support that this project has inspired. Now working with a dedicated team of 20 volunteers, BioFoundry hopes to expand on the valuable research and development performed by CCL. It’s been an exceptional example of online, open collaboration in the 21st century, simultaneously revealing the power of citizen science and the limitations of the academic sector to respond dynamically to changing market conditions.
How can YOU help?
If you’re interested in getting involved in the science here at BioFoundry, or wish to reproduce/advance our results in your own lab…
If you’re interested in the economics of this unique problem and wish to get to grips with one of the 21st century’s biggest oligopolies…
If you’re interested in the engineering challenges, supply chain management and Insulin Delivery Devices…
Then get in contact with our team: