We are creating an open source (freely available) model for insulin production built around small-scale manufacturing and open source techniques for production. We are developing organisms and protocols to produce rapid acting (lispro) and long acting (glargine) insulin. Additionally, we are working on developing open hardware equivalents to proprietary production equipment, are researching regulation pathways to bring our insulin to the public, and are developing plans for local, small-scale manufacturing pilots.
We are engineering microorganisms to produce long-acting (glargine) and short-acting (lispro) insulin analogs using standard techniques in biotechnology. We work with both bacteria and yeast. Our work is based on academic publications and off-patent processes. Our volunteers run experiments at our community labs in the US: Counter Culture Labs in Oakland, CA; Baltimore Underground Science Space (BUGSS) in Baltimore, MD; and an Open Insulin chapter in Paris. To learn more about our work in the lab, watch a quick video featuring our scientists Max and Yann.
To produce the protein needed for insulin, we need to grow microorganisms with a bioreactor and purify the protein from the culture with a protein purification system. Proprietary versions of such equipment come at a very high initial cost and with high ongoing costs of support from the manufacturers. Our goal is to develop easy to manage, easy to repair, and affordable equipment to sustain local and community-built insulin production.
We have an FPLC design in the early stages of development, focusing on one component, a UV absorbance detector, as well as peristaltic pumps and a mixing chamber. We also have a bioreactor design which makes use of inexpensive, commercial off-the-shelf parts and is ready for prototyping.
In addition to insulin production, open hardware could be used for research and pedagogic purposes in addition to small scale manufacturing and we are looking forward to contributing it to the biohacking community in general.
We are investigating regulatory pathways at the federal, state, and local levels. We are also exploring the possibility of reducing the costs of regulatory compliance without compromising safety by confining production to the state or local level. To learn more about the possibilities for bringing our insulin to the public, see The Open Insulin Project: A Case Study for ‘Biohacked’ Medicines (2018).
We are looking to expand our network of experts and advisors who have a background in regulatory compliance and are interested in developing and advocating for regulatory models appropriate to decentralized, local-scale production. Connect with us!