The largest pharmaceutical company in Japan, Takeda first set up operations in Ireland in 1997 manufacturing products for global markets.
In 2002 Takeda chose Dublin as the location for its first active pharmaceutical ingredient (API) facility outside of Japan. In 2017 Takeda also announced an investment in the construction of a stand-alone production facility for the manufacture of part of their oncology portfolio at Grange Castle.
The latest investment by Takeda will expand the existing Grange Castle site’s footprint, with the construction of a new standalone modular cell therapy facility dedicated to manufacturing the novel stem cell therapy product “Alofisel” (darvadstrocel). Alofisel is a suspension of allogeneic expanded adiposederived stem cells (eASC) locally administered for the treatment patients with perianal fistulae associated with Crohn’s disease.
The new facility will be in full commercial operation by 2021, requiring personnel to demonstrate a unique set of skills, mind-set and behaviours. To address these needs Takeda requires that all personnel undergo an introduction into aseptic processing and cell therapy as part of Takeda’s on-boarding.
Takeda and NIBRT formed a collaboration to develop a customised baseline training program for the Alofisel team. This introduction is a prerequisite to all subsequent training, providing the foundation for Grange Castle to become the centre of excellence for stem cell manufacturing within the Takeda network.
The customised course for the ALOFISEL manufacturing process is a very hands on approach with the extensive use of NIBRT’s facilities and laboratories. The training curricula includes an assessment of competency pre and post the training which will form part of the overall training records for Takeda personnel with special focus on working in biological safety cabinets and the use of isolator technology.