Belgium-based TiGenix announced it received the Spanish Medicines Agency (AEMPS) license this week, explaining the Madrid plant will provide capacity for production of its portfolio of cell therapies including the candidate cell therapy Cx601.
Chief technical officer Wilfried Dalemans said: “We have now significantly increased our manufacturing capacity, a key step in the preparation for commercialization of Cx601 in Europe and in the further development of our pipeline.”
Cx601 has been accepted for review by the European Medicines Agency (EMA) and Swissmedic, which began reviewing TiGenix dossier in June.
At the time the firm told us Takeda will take over responsibility for making the cell therapy from 2021 but did not provide additional details.
Cx601 is made from stem cells taken from donor adipose tissue. It is being developed for the treatment of complex perianal fistulas in patients with Crohn’s disease patients who do not otherwise respond to standard therapies.
The therapy is made in a 2-dimensional cell culture.
TiGenix expanded the Madrid facility with support from Japanese drug firm Takeda, which licensed rights to commercialize Cx601 outside the US.
In the US, TiGenix has hired Lonza to make Cx601.
In February, the Belgian biotech said Lonza is transferring manufacturing technologies to its facilities in the US, adding that the Swiss contractor is poised to begin making the product for clinical trials.
A TiGenix spokeswoman told us "Lonza will manufacture material for the global Phase 3 trial of Cx601 in the US at Lonza’s cell therapy production facility in Walkersville, Maryland (US), and the GMP facility will support the potential initial European commercial roll out of Cx601."
She added that: "The expanded facility will also provide capacity for the manufacturing of other pipeline products under development by TiGenix, including Cx611, currently undergoing a Phase I/II trial in severe sepsis."