3 ms·
regulatory compliance for biologics (stuff made by living things) is a bitch compared to normal chemicals... maybe the generics companies don't find it worthwhi
by xkcd-sucks 12y ago
regulatory compliance for biologics (stuff made by living things) is a bitch compared to normal chemicals... maybe the generics companies don't find it worthwhile.
on the other hand, making insulin with transgenic bacteria is practically kitchen chemistry, if you're not scared of injecting yourself with your own product.
- dnautics 12y agoYou can't make insulin from bacteria that easily. It's a two chain protein, and stitching together the two chains kinetically competes with precipitation of one of the chains. One chain insulins are typically ineffective (well someone did once engineer a working single chain insulin - Michael Weiss at Cass Western) because signalling requires insulin to unfold, which down not happen when the chains are attached to each other. If you try to design an insulin analog yourself be careful. Insulin cross reacts with the igf-i pathway; igf, like most growth factors, is oncogenic, so you'll have to be vigilant about getting cancer down the line.
- dnautics 12y agoI'd like to add that it might not be impossible to spin up production of a generic low cost insulin... Or to develop direct to generic IP free insulins, but the newer insulins are preferred because of very nice pharmacodynamic properties. That said, the bestiary of insulins we have now is quite comprehensive and as they fall off the patent cliff I think the future looks nice for generics
- xkcd-sucks 12y agooops, thought it was a simple short peptide... refolding from inclusion bodies is still kitchen chemistry, although it probably wants some expensive chromatographic cleanup regardless of how it's made. since pancreas is essentially a waste product, maybe it's easier to do that and the switch to recombinant insulin was for consistency/better analogs.
- refurb 12y agoI would guess it has more to do with demand. Once recombinant insulin came out, most folks switched, a few didn't. Unfortunately, "a few patients" aren't enough to support an entire product line.