Takeda Pharmaceuticals International AG
Location: Madrid, Spain; Grange Castle, Ireland; Osaka Japan; Thousand Oaks, California, USA
Project: Alofisel Global Program
Takeda Pharmaceuticals International AG, founded in 1781, is a patient-driven, R&D-focused pharmaceutical company with headquarters in Tokyo, Japan. Its mission is to strive toward better health for people and a brighter future for the world through leading innovation in medicine.
Alofisel is a first-in-class stem cell therapy product and the first allogeneic mesenchymal stem cell therapy to receive approval by the European Medicines Agency. The project was designed with a product shelf life of only 48 hours and requires seamless cold chain transportation. Takeda had to completely rethink the supply chain to get the product from the plant to the hospital to be administered to the patient within a very short time frame.
The program is recognized in this year’s awards for its novel and innovative approach to end-to-end supply chain management as well as the program’s innovative design in expanding the Alofisel manufacturing network from its initial plant in Madrid, Spain, to other regions across the globe with new facilities in the US, Japan, and Ireland.
The program’s implementation included the introduction of a bespoke world-class end-to-end supply chain introducing a made-to-order process under one IoT solution. This included the implementation of a cloud-based control tower function, the first of its kind at Takeda. It provides the interfaces to coordinate between clinic, manufacturing, and logistic providers who specialize in the cold chain transport of living organs for transplant surgeries. This dynamic approach enables hospitals to book a manufacturing slot via an SAP Leonardo web portal, which includes order status monitoring, on-time delivery tracking by GPS, and end-to-end coordination from “plant to patient”. This innovative supply chain ensures that the product is available to the patient in less than 48 hours from the manufacturing plant.
With the planned launches, Takeda Global Manufacturing and Supply function undertook the challenge to expand the Alofisel manufacturing network to support the supply to other geographies. In doing so, the individual project teams were empowered to introduce innovative manufacturing designs to new facilities across the globe. Running these projects under one program enabled the rapid transfer of processes and technologies from site to site. The highest standards of facility design ensured a highly efficient and right-first-time manufacturing process. The introduction of rapid testing methods enabling the real-time batch release of the product to the patient further supported the seamless end-to-end supply chain.
By putting the needs of the patient at the very heart of this program, Takeda has demonstrated the industry’s ability to use IoT solutions to bring manufacturing rights to the patient to overcome shelf-life challenges which may be presented with new and novel products in the coming years.
To that end, the Alofisel Program is the FOYA 2022 winner in the category ‘Supply Chain’ as it exemplifies the application of a novel and innovative supply chain management in bringing this product from “plant to patient” in 48 hours.
Supply Partners and Key Participants:
Manufacturer/Owner Name:
- Takeda Ireland Ltd (Grange Castle)
- Takeda Pharmaceuticals
- Takeda Pharmaceutical Company Limited; Osaka Plant
Engineer/Architect (A&E):
- McElroy Associates
- Tandem Project Management
- KLINEA
- Axiom
- ESTUDIO G&B
- Taisei corporation
- CRB Engineers
Construction Manager:
- John Sisk & Son (Holding) Limited
- Axiom
- Taisei corporation
- CRB Engineers
Main/General Contractor:
- ALBIAN (INGECLIMA, SL)
- Taisei corporation
- CRB Engineers
Piping Subcontractor:
- AFARVI
- Taisei corporation
- Pan Pacific Mechanical
HVAC Subcontractor:
- ALBIAN (INGECLIMA, SL)
- Taisei corporation
- Pan Pacific Mechanical
Automation and Control Suppliers:
- OASYS
- Johnson Controls, K.K.
- Taft Electric
Major Equipment Suppliers/Contractors:
- SKAN AG
- Ortner Reinraumtechnik GmbH
- Telstar
- BSC etc.
- Azenta Life Sciences
- SKAN Japan