Insulin that can be made near the people who need it
editorialTherapeutics · early attempts · hardest part: manufacturing, regulatory, capital, science
A century-old biologic with a concentrated supply chain. The molecule is not the obstacle; the manufacturing and regulatory route for a small producer is.
This is editorial, not a record. Registry entries are cited facts about things that exist; an opportunity is our argument about something that does not. The links to existing work are checked against the catalog — the judgment around them is ours, and you should disagree with it where you know better.
Insulin production is dominated by a small number of manufacturers operating at very large scale. Modern analogues carry patent protection, and biosimilar approval demands comparability data that is expensive to generate. Scale economics and regulatory cost together mean a small producer cannot enter even where the underlying protein is long off patent.
A published, reproducible production process at small scale — expression, refolding, purification, formulation — with the analytical package to demonstrate identity, potency, and purity batch to batch. Then a regulatory route that a non-corporate producer can actually follow. Open work exists at the research stage and has not crossed into anything a patient could inject.
People rationing insulin, which is a documented cause of death in wealthy countries as well as poor ones.
Community effort to develop a decentralised, locally ownable model for producing safe and affordable insulin.
- openinsulin.org/retrieved 2026-08-05 · via manual
The Open Insulin Foundation describes itself as working on technology research and development toward decentralised production, which supports the characterisation of open work as pre-clinical rather than deployable.
Last revised 2026-08-05.