Xintela has now taken a big step forward in the stem cell project by initiating the construction of its own GMP manufacturing facility for the production of horse as well as human stem cells. This is an important step for Xintela, which shows that our strategy is to become a complete and competitive company in regenerative medicine. Through our own manufacturing facility we will be able to build a stem cell platform for the development of new therapies in several therapeutic areas.
The decision to set up our own GMP production unit, initially for the production of horse stem cells, was not only of strategic importance but was also necessary since our evaluation of potential contract manufacturers in Sweden revealed that they cannot produce our horse stem cells in conjunction with the production of human cells. It would have required both the rebuilding of these facilities and new permits. In our own facility, we get full control of and flexibility in production, saving us both time and money.
It is also a great advantage to locate the GMP unit in direct conjunction with our premises at Medicon Village in Lund, which means that we can use our resources more efficiently. Since we need time to build and equip the GMP facility and to establish processes and a quality system for stem cell production, the clinical trials on horses will start somewhat later than initially planned, which means not earlier than 2018. However, it is of great importance that we will be able to start clinical trials in humans, for the treatment of osteoarthritis, earlier than planned.
In this newsletter we present an interview with Liselotte Theorell, who is responsible for construction of our production facility andestablishing processes and quality systems for the production of stem cells for clinical studies. She presents her experiences in the field and why the establishment of our own manufacturing facility is the right way to go for Xintela. We also tell about an interesting new study showing that the number of people suffering from osteoarthritis is increasing significantly. This demonstrates that Xintela’s work in regenerative medicine is of great important and that the market for osteoarthritis treatments is indeed increasing.
Our activity levels are also high in our other projects with the main focus on collaboration partners for our XACT quality test and for our cancer project. Through our participation in several partnering meetings during the last six months, we have established a number of exciting contacts with international companies. We are working full speed with the goal to announce important progress before the end of the year.
Have a lovely autumn,
Evy Lundgren-Åkerlund
CEO, Xintela AB
