Meet the 2022 FOYA Supply Chain Category Winner: Takeda
FOYA Winners in the Supply Chain Category exemplify the novel application of process manufacturing techniques, innovative design concepts, new technologies, and unique solutions that exemplify the next generation of agile, flexible, efficient, and effective new and existing pharmaceutical and biotechnology facilities. This includes implementation of commercially available and custom developed equipment which yielded superior results, improved competitive position, and/or demonstrated imaginative collaboration with vendors/suppliers/manufacturers.
Takeda won the FOYA in the Supply Chain Category for developing a unique supply chain and innovative engineering solution to deliver custom-made medicine to patients in less than 72 hours.
Approximately 20% of adults suffering from Crohn’s disease are affected by complex perianal fistula, a chronic complication, with painful and extremely uncomfortable symptoms, that severely impacts the patient’s quality of life. Takeda’s stem-cell therapy is a live human mesenchymal stem cell treatment used to treat adult patients with non-middle active luminal Crohn’s disease, when fistula have not responded to conventional or biologic therapies. Mesenchymal stem cells are adult stem cells isolated from different sources that can differentiate into other types of cells. Because of the nature of this living cell formation, the shelf life for the product is 72 hours.
The entire finish product process is up to ten days long and is truly a make-to-order process where doctors can order patient treatment directly via a web portal and track when the treatment is ready for shipment and anticipated delivery date. The innovative and highly integrated approach from enterprise to equipment was made possible through solution standardization and strong cross functional collaboration across different departments and facilities within Takeda.
In addition to the supply chain advancements, Takeda combined and implemented cutting-edge technologies. One major advancement in the manufacturing process was the achievement of a parametric release to enable real time batch release, reducing the need for detailed retrospective batch review. Given the short shelf life of the product, four rapid and real time test methods give early warning signs of any production issues, days, if not weeks, earlier than traditional test methods.
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 stem-cell therapy manufacturing network from its initial plant in Madrid, Spain, to other regions across the globe with new facilities in the US, Japan, and Ireland. 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 right 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 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 72 hours.
About Takeda: Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet.
Nominate Your Facility for the 2023 FOYA Program!
Apply for a chance to join this prestigious list of innovative game-changers and let ISPE honor your organization as a 2023 FOYA program winner. Applications must be submitted by 2 December 2022.
Digital Transformation (DT) is impacting every aspect of our personal and professional lives, so it was no surprise that nearly one-third of all presentation proposals for this year’s ISPE Annual Meeting involved DT topics. It is a testament to the breadth of DT that there are three ISPE Communities of Practice (CoPs) operating in this space, each of whom had submitted high-quality...
The ISPE Drug Shortages Initiative Team conducted a webinar on 9 February 2023 to discuss regulatory and industry insights on drug shortage prevention with a focus on the Asia-Pacific region. The webinar was moderated by Vivien Santillan, Regional Director, Asia, Novatek International. Regulatory speakers were Lisa Hedman, Group Lead for the Division of Supply and Access to Medicines of the...
Following the recent surge in popularity of mRNA technology due to Covid-19 vaccines, we are beginning to realise its impact and potential in this field and for oligonucleotides. However, we face a steep learning curve in understanding the diversity and specifics of the manufacturing chain that make this new generation of RNA drug products completely different from traditional biologics (e.g....