In this development project, a recombinant lipase obtained from the fermentation of bacteria is purified from the culture supernatant under GMP conditions.
This purified enzyme is tested in clinical trials with patients suffering from the failure or impairment of the pancreatic digestive function (exocrine pancreatic insufficiency, EPI). The product is differentiated from traditional pancreatin products by the following characteristics:
- Acid stability
- High specific activity
- Liquid formulation
Compared to standard drugs, these properties could offer distinct advantages to patients in terms of both application and use. This project is based on Nordmark’s extensive experience in drug development for the treatment of EPI.