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Astellas Pharma and YASKAWA Electric Corporation have signed a definitive agreement that officially commences a joint venture that revolves around the design of a cell therapy product manufacturing platform using Maholo, a dual-armed, humanoid robot created by the Robotic Biology Institute, a YASKAWA subsidiary.1
The partnership is expected to provide academic and startups platform access to the platform as well.
As pharma supply chain stakeholders may be aware, there are various obstacles surrounding cell therapy commercialization, including the complexities related to the manufacturing process, such as the task of accurately being able to reproduce cells. Time, cost, and hiring a skilled workforce that is knowledgeable of the tech also present challenges.
All of these challenges are ongoing, amid trying to address FDA’s forecast of approving 10 to 20 cell and gene therapy approvals (CGT) per year by 2025.2
“So really, I think partially the complexity of development and manufacturing of these therapies—there’s incredible complexity to understanding how to not only manufacture and scale according to different patient populations that need to be targeted, so navigating some of those challenges from the development and manufacturers perspective, but then also understanding what the regulatory hurdles may be,” explained Jenna Dale, Cencora’s director of client relations, in an interview3 with Pharma Commerce. “How do we effectively understand the outcomes that we’re trying to study in the clinical trial setting that ultimately will help us achieve a regulatory filing approval and eventual launch?
“ … There’s also COVID. COVID did a number on the entire sector. We really saw a decrease in financing and funding available. We know that these therapies are incredibly complex and require a high cost of investment to develop and ultimately achieve a commercial launch. Navigating funding hurdles as well has been a challenge, and I think really slowed some of the progress to an extent. And then finally, I think the workforce and expertise shortages come into play here. As a sector, the cell and gene sector is still relatively in its infancy stages, and so finding folks that have had an opportunity to work through the development and commercialization, both on the manufacturing side and from the regulatory agencies perspective as well, just to understand these therapies, and ultimately, how to develop and commercialize them. I think all of those things have really factored into why we haven’t yet achieved the goal, but the exciting part is, I see a lot of progress being made in each of these areas that hopefully will start to see us catch up to that goal a little bit more quickly here in the near future.”
Talks pertaining to this specific collaboration dates back to May of last year, during Astellas and YASKAWA signed a memorandum of understanding,4 signifying early talks to design a cell therapy ecosystem with the use of pharmaceutical and robotics technology.
References
1. Astellas and YASKAWA Agree to Establish a Joint Venture Focused on Cell Therapy Manufacturing. PR Newswire. March 5, 2025. Accessed March 6, 2025. https://www.prnewswire.com/news-releases/astellas-and-yaskawa-agree-to-establish-a-joint-venture-focused-on-cell-therapy-manufacturing-302394019.html
2. Statement from FDA Commissioner Scott Gottlieb, M.D. and Peter Marks, M.D., Ph.D., Director of the Center for Biologics Evaluation and Research on new policies to advance development of safe and effective cell and gene therapies. United States Food & Drug Administration. January 15, 2019. Accessed March 6, 2025. https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-and-peter-marks-md-phd-director-center-biologics
3. Saraceno N. Tackling Gaps in Manufacturing, Funding, and Expertise. Pharmaceutical Commerce. February 10, 2025. Accessed March 6, 2025. https://www.pharmaceuticalcommerce.com/view/tackling-gaps-in-manufacturing-funding-and-expertise
4. Saraceno N. Astellas, YASKAWA Sign Cell Therapy MoU Powered by Robotics Technology. Pharmaceutical Commerce. May 21, 2024. Accessed March 6, 2025. https://www.pharmaceuticalcommerce.com/view/astellas-yaskawa-sign-cell-therapy-mou-powered-by-robotics-technology