Heparin is a medicine that is often used in hospital settings. It’s used as an anticoagulant/blood thinner to prevent clotting in patients with cardiovascular diseases as well as for other conditions such as hemodialysis. However, because of the unsustainable way it’s produced, it’s challenging to meet demand and keep the supply chain of heparin safe for patients. ExCulture is working on the development of a fermentation process that has the potential to provide a safer way of producing heparin on a larger scale. Co-founder Ilaria Poledri talks about its impact.
The dark side of heparin
“Heparin is a byproduct of pig slaughter,” explains Ilaria. “The intestines from the dead pigs are scraped, and heparin is extracted through a very extensive separation and purification process. However, the yield is very low, making this process inefficient. Furthermore, this process is also very unstable as heparin comes from animal tissue. It’s uncontrolled and unsafe. For example, during the swine flu epidemic, the supply couldn’t meet the demand anymore, which led to a contamination crisis that caused the death of many people. Ever since 2017, heparin has been on the US FDA drug shortage list. On top of that, the Netherlands imports the largest portion of its heparin supply from the US, which in turn imports it from China. About 80% of the US’s supply chain of heparin comes from China, which makes the Netherlands indirectly dependent on China. That poses security and geopolitical issues. That’s why we want to step in with ExCulture.”
Transforming the process
Ilaria and co-founder Aisling Foley aim to transform the production method of this life-saving pharmaceutical. “We want to future-proof the heparin supply chain by removing the dependency on animals and high-risk countries,” says Ilaria. “Based on 30 years of research carried out at the TU Delft, we are developing a fermentation process similar to that implemented in wastewater treatment, aiming to use more environmentally friendly and abundant sources of feedstocks while maintaining sterile, controllable lab conditions. Contrary to our competitors, we’re not using a synthetic approach, we’re not using chemical synthesis, and we’re also not using bio-engineered enzymes. We’re just using the natural production method that we find in this fermentation bioprocess. The benefit is that we can easily scale up the upstream part. Now we’re trying to figure out the best method for purification of the heparin compounds, the downstream part.”
Structuring business
With TTT’s help, they could focus on the business side. Ilaria: “Esther helped us from the beginning, from our application assessment to now. At the start, we had to pivot, which enabled us to gain more focus. Furthermore, we participated in a couple of workshops organized by TTT which helped us a lot in structuring our business research. For example: how do we interview experts and potential customers? How can we get insights regarding the whole supply chain? And how do we set up our regulatory strategy? We still need to work out details, but it really gave us structure. Participation in TTT also gave us access to a wide network and conferences such as Innovation for Health. We’re really happy about that, and we believe this will increase visibility and traction.”
Safer and more sustainable healthcare
So what’s next for ExCulture? Ilaria: “If everything goes as planned, we can set up our lab in September this year. Furthermore, we’re working on attracting talent for our team, so we can spin out and work toward commercialization. In 5 years, we aim to have our technology ready so others can take a license and use it as well. That way, we can get heparin off the US FDA drug shortage list and make production safer and more sustainable. Eventually, ExCulture wants to contribute to healthcare which is better for patients and the world.”