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as a citizen of a country whose government (-owned company) makes insulin, this reads weird to me

good. generic biosimilars cost like 1/5 of the on-patent thing price

fyi this fella has no training in chemistry or medicine and is just some random ass programmer with severe case of "saving the world from my homelab" symdrome

I don't think it's a thing because even the same insulin analogue from different manufacturer can have different dosing

90% of drug candidates fail in clinical trials

couple of reddit threads suggest that this is something you can do, but you have to be evasive around american border guard later if you go in person

i mean i don't think about it as a separate budget line because if you don't have that you get police raids and investigation instead of normal business, but yea. insulin is purified using HPLC, so at all times you get some of analytical data about fractions you just made, so some of QC, not all, but already something, already happens at this point

my point is that actual manufacturing costs will be low because biotech scalability logic is that you need to make yeast or something that makes peptide you like and then all you need to do is keep bioreactor alive and happy. lots of what is left is in purification

also it's an injectable so it's gonna be kept to some standards that non-injected drugs aren't. whoever comes up with insulin pill will be printing money

there are multiple short-acting and long-acting insulins because you can't patent other people's things, but now it's all off-patent. just take your stainless steel bioreactor and preparative HPLC, cook up a batch, wait ten years for biosimilar approval and you're good to go

because unlike with small molecule drugs, when cooking up generic biopharmaceutical there’s extra approval process that amounts to a tiny clinical trial https://en.wikipedia.org/wiki/Biosimilar this and type of economics of scale that there is with biologicals makes manufacture at large scale way more preferable. these requirements were loosened a bit over time

I know not every state can or are willing to do this

this kind of thing scales well, i see no reason why after california has it set up, other states couldn't get insulin from them, or chip in

it might just be in glass vial and freezing broke it

you know maybe it's a good thing that people can't sleep on ceiling, everybody's rent would double