Disease versus sensitivity
The most severe reactions occur in the 1% of the population who suffer from celiac disease, a genetic autoimmune disorder that makes it impossible to safely consume any food that contains gluten. Those with non-celiac gluten sensitivity generally have milder reactions: this is the group the Tolerase G application is designed for. Tolerase G is not intended to replace a gluten-free diet and is not intended to treat or prevent celiac disease.
Extending the solution
DSM Scientist Luppo Edens identified the AN-PEP enzyme: "Gut health has been on DSM’s radar for a long time. We began screening many years ago for an enzyme that would specifically cleave proline-rich protein fragments, making it easier to break down food proteins that cause problems. We had first identified AN-PEP during milk protein allergy research, and realized we could extend the solution to gluten".
Years of research, development and testing were required to ensure safe and effective application of the enzyme. In this, DSM received indispensable support in an academic partnership with Professor Frits Koning – a renowned gluten and celiac disease expert at the University of Leiden. “The specialized knowledge, technology and techniques at his disposal were essential from beginning to end,” says Edens.
Safe for consumption
The first in vitro tests, which took place in 2006-2008, proved that AN-PEP could break down the problematic gluten fragments, including those in a typical hamburger meal. Subsequent in vivo studies demonstrated the safe character of the enzyme when consumed. This led to its first application in food products that contain gluten.