Aminolipine for formaldehyde-free fixing of biological materials
GO-Bio round 8 – Prof. Bernhard Hirt – Institute for Clinical Anatomy and Cell Analysis, Eberhard Karls University of Tübingen
Beneficiary: Eberhard Karls University of Tübingen
Owing to its diverse properties, the chemical formaldehyde is used not only in the fields of industry, anatomy and pathology, but also by funeral homes. It is the most common agent used to fix and conserve human body donations, organs and tissue. Yet formaldehyde is highly toxic and has been proven to be extremely harmful to health. In 2015, Germany therefore decided to reduce drastically the permitted concentration of formaldehyde in the workplace. It can be used only under strict conditions. Since 2016, Europe has officially considered formaldehyde a probable human carcinogen, and it has been classified as likely to cause genetic mutations. Up until now, the market lacked an alternative substance, which greatly limited the work that could be carried out in anatomy, pathology and the funeral home sector.
Researchers led by Tübingen-based physician Bernhard Hirt have developed a formaldehyde-free replacement substance. After multiple screenings, they settled on aminolipine, a pyrrolidine derivative. It can be produced from naturalistic substances through chemical synthesis. Coconut oil is one of the materials used for that purpose. The Tübingen-based scientists were able to prove in numerous experiments that aminolipine is highly suited to the fixing and conservation of biological materials – such as tissues and organs – and for embalming bodies. The benefit of aminolipine-based products: unlike formaldehyde, they not only effectively inhibit functional proteins such as proteinases, but they also have anti-microbial effects.
The GO-Bio grant will be used specifically to prepare aminolipine for commercialisation as a formaldehyde-free alternative for use in anatomy, pathology and the funeral home sector. The plan is to perfect the manufacturing process in the first GO-Bio phase. It is currently possible to synthesise approximately 5,000 litres of aminolipine, which is equivalent to the amount required by a single anatomy institute each year. The grant is to be used to scale up the production process to enable it to supply at least all of the roughly 35 anatomy institutes in Germany and, in the long term, approximately 350 institutes around Europe. In addition to enhancing production, the GO-Bio project will be used to develop other modified aminolipine derivatives. This promising substance will also be tested for carcinogenicity, toxicity and bio-compatibility based on the EU Biocides Regulation. The efficacy of aminolipine as a fixing and conservation agent will in turn be tested in an international, multi-centre study. If proof of concept is successful, a start-up will be established at the end of the GO-Bio stage. In addition to Germany, the project also aims to target the Asian market in the long term. There are roughly 600 anatomy institutes in Asia, and the research team has already started partnerships with some of those organisations.