A team of biohackers from California, in the US, are developing open-source insulin in order to make the peptide hormone easily available to millions of diabetics across the world.
The team with Counter Culture Labs — a community lab — has already started a crowdfunding page in order to fuel their project. They aim to create and refine synthetic insulin from E coli bacteria and also document the process.
The biohackers hope a generic pharmaceutical company will use the protocol they develop to make insulin every single diabetes patient across the globe can afford.
There are various kinds of insulin approved by the US Food and Drug Administration (FDA). Some are long-lasting while others are fast-acting, but they're all reportedly guarded by patents, so no generic version is available.
Once the Counter Culture Labs team's protocol is finalised, pharmaceutical companies will have to seek approval from the USFDA to make generic insulin.
"It takes legitimate scientific research to create a biosimilar generic [drug], and generic companies don't want to do scientific research," said Maureen Muldavin, a programme manager at Counter Culture Labs and a biohacker associated with the Open Insulin project.
Muldavin said biosimilar drugs, especially insulin, are difficult to create due to their complex structure. "It's not as simple as putting the genetic code [in the bacteria] and out pops insulin," she said.
The insulin the team is working to produce from E coli cannot be directly injected into human patients without refining it. Therefore, they have said they will need to check if the hormone can be made feasible through tests with antibodies.
However, Kevin Riggs, a medicine instructor at Johns Hopkins University, who co-authored an article dealing with generic insulin earlier this year, is sceptical about this process being enough to get generic insulin to the market.
"I don't think the major hurdle is that the companies don't know how to make insulin, because that part is reasonably straightforward," Popular Science quoted him as saying.
He said getting the USFDA's approval — as insulin is a biologic drug that needs more original data than any small-molecule generic would — and bearing the "upfront manufacturing costs" are the "real hurdles".
He added that it would require "an altruistic entity with a lot of startup money" to create generic insulin commercially available.
Regardless of all the difficulties, biohackers are determined to create open-source insulin because they want to show they, too, can make important scientific contributions without an established world-class laboratory.
However, Muldavin warned that their mission doesn't encourage brewing insulin at home, adding that that possibility is nearly 20 years away.
In order to prepare open-source insulin, the biohacker team has to raise more than $3,000 in 16 days.
Across the world, 370 million diabetic patients depend on injections to regulate their insulin levels. Owing to the absence of generic insulin in the US, insulin is very costly, with nearly $176 billion of medical expenditures in the country coming from diabetic patients in 2012 alone, reported Popular Science.
According to the World Health Organisation, 9% of adults showed prevalence of diabetes globally in 2014. The disease is also estimated to become the leading cause of death by 2030.