1. QP Forum 12 April 2018 Trinity College, Dublin Ireland
Takeda Pharmaceuticals International AG
Susan Armijo
Global Quality Product Leader Cell Therapy Products

2. Alofisel® (darvadstrocel) receives approval to treat complex perianal fistulas in adult patients with Crohn's disease in Europe
First allogeneic stem cell therapy to receive central marketing authorization approval in Europe
Designated as an orphan drug by the EMA and Swiss Medic in Switzerland
Current manufacturing in Madrid
Technical Transfer to Takeda Grange Castle site in Ireland

3. 2,400 patients
Local administration of expanded adipose-derived stem cells (eASCs) for the treatment of complex perianal fistulas in Crohn’s disease patients. The treatment is administered as a single dose.

4. Key Challenges
Shelf life
Product release in 2 stages
Shipments
Product specific requirements necessitating dedicated SOPs