That's on first glance a really nice project and goal but $12K to create a generic insulin is not going to cut it.
That will barely get you a kitchen, not a laboratory that will produce something that will pass FDA approval after you spend a very large multiple of that on tests.
There are already multiple lab spaces online with many active members participating in this project.
As far as FDA trials go, it is something currently outside the scope of this campaign. This is from the crowdfunding page:
"
$6,000 is needed to initiate Phase I of the project. In Phase I, the team will insert an optimized DNA sequence for insulin into E. coli bacteria, induce the bacteria to express insulin precursors, and verify that human proinsulin has been produced.
If we raise more than the minimum required for Phase I, we will proceed to establish the protocols for cutting and folding the proinsulin into its final, active insulin form, and develop purification methods sufficient for research and potential pharmaceutical use.
All protocols we develop and discoveries generated by our research will be freely available in the public domain. We will also be proactively investigating strategies to protect the open status of our work.
That still seems incredibly cheap to me. On another note, I'd be happy to back your campaign (I'd see it as contributing to your education rather than that I would expect you to succeed but that's just my totally un-informed opinion), but the requirement for becoming a backer are apparently that one signs up or uses facebook and that's a bridge I will not cross for any good cause. Is there some other way I can contribute?
It is indeed a low number as far as science research goes.
It's pretty staggering how inexpensive experimenting with DNA can be. Recent advances in DNA synthesis are outpacing Moore's Law. Creating genetic constructs for insulin is also cheaper because insulin itself is a relatively simple protein.
And fortunately there are also a ton of extremely qualified people on the team who seem to love working for free.
EDIT: you shouldnt need to use facebook. you can sign up for experiment .com with just an email addy.
I don't want to sign up for anything, I want to back your campaign. If your project has a direct way of receiving some funds let me know, email address in my profile.
What's the goal of the project, is it to produce cheap insulin, or is it to validate "open-source biohacking"?
If it's the latter, why start with such a hard molecule; isn't there a lower-hanging fruit?
If it's the former, it would seem grounded in the assumption that biosimilar insulin unavailability in the Western markets is due to the lack of a royalty-free production method. I'm not sure that is the case (and please, correct me along the way). Biosimilars face a more rigorous/expensive approval process than generics (as they should), they're more expensive to produce under GxP conditions, and they're more expensive to store/transport/etc—the upfront costs are higher, the production costs are higher, and the logistical costs are higher. A small portion of NRE costs in the beginning would seem to be a drop in the bucket compared to the rest. Are you planning to address the rest of the lifecycle? Also, there would seem to be a lot of handwaving over the folding problem… do you have direct plans to address it?
I don't intend for this to come across harshly—I'm genuinely curious and hope this comes across constructively.
> In Phase I, the team will insert an optimized DNA sequence for insulin into E. coli bacteria
That is an unfortunate naming choice. Phase + Roman numbers have a well defined meaning in drugs development (clinical trial phases). I saw you refer to phases elsewhere in the comments and misunderstood what you meant.
That will barely get you a kitchen, not a laboratory that will produce something that will pass FDA approval after you spend a very large multiple of that on tests.