TiGenix obtains production licence for expanded adipose-derived stem cells in Spain
Belgian biopharmaceutical company TiGenix has received a licence for the commercial production of expanded adipose-derived stem cells (eASCs) at its extended manufacturing facility in Madrid, Spain.
The company uses the anti-inflammatory properties of allogeneic or donor-derived stem cells to develop new treatments for serious medical conditions.
The commercial production licence was secured by the company after an inspection conducted by the Spanish Medicines Agency (AEMPS).
The licence provides capacity for the potential initial commercial roll out of Cx601 across Europe.
Cx601 is an investigational stem cell therapy used to treat complex perianal fistulas in patients with Crohn's disease, a chronic inflammatory disease of the intestine.
Additionally, the extended manufacturing facility will offer sufficient capacity for the production of other pipeline products, including Cx611, currently under development by TiGenix.
Currently undergoing a Phase I/II trial, Cx611 is an intravenous administration of allogeneic eASCs for the treatment of severe sepsis, which is a life-threatening complication of infection that results in systemic inflammation and organ failure.
TiGenix chief technical officer Wilfried Dalemans said: “We are very pleased with this approval for our expanded facility, which confirms our state-of-the-art good manufacturing practices (GMP) manufacturing capabilities in the stem cell field.
“We have now significantly increased our manufacturing capacity, a key step in the preparation for commercialisation of Cx601 in Europe and in the further development of our pipeline.”
TiGenix has recently given an exclusive development and commercialisation licence for Cx601 outside of the US to Takeda.