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- Pioneering cell therapy innovation through robotics and AI -
- Among the first innovator pharmaceutical companies granted AMT designation -
- Enabling early, priority engagement with FDA to accelerate development -
TOKYO, December 18, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the U.S. Food and Drug Administration (FDA) has granted an Advanced Manufacturing Technology (AMT) Designation for the Maholo Robotic Cell Culture Automation System. This designation, awarded by the FDA’s Center for Biologics Evaluation and Research (CBER), recognizes technologies that enhance manufacturing and supply reliability, product quality, and drug development speed. Maholo is among the first pharmaceutical technologies to receive this designation, reflecting its innovative integration of groundbreaking robotics and AI to address challenges in cell therapy manufacturing. Cellafa Bioscience, a joint venture between Astellas and YASKAWA Electric Corporation, will drive the practical use of this technology.
Rao V. Mantri, Ph.D., M.B.A., Chief Manufacturing Officer, Astellas
“Manufacturing living cells is inherently complex, and in cell therapy, the process truly defines the product. Receiving the AMT designation for Maholo marks a major milestone in advancing our manufacturing capabilities and underscores our commitment to delivering innovative therapies to patients. Maholo is a cornerstone of our strategy to build the infrastructure needed to set a new industry benchmark for quality, scalability, and development speed in cell therapy.”
Cell therapies aim to rejuvenate, regenerate and replace damaged tissues, creating new opportunities for treating disease. However, manufacturing cell therapies is challenging because cells require extensive manual handling, making it hard to ensure consistent quality and uniformity. To address this, the Maholo system features dual-arm robotics that ensure high reproducibility and precision, utilizing AI to optimize the automated process from the initial stages of cell therapy development.
Hideto Yamaguchi, Ph.D., President & CEO, Cellafa Bioscience
“Cellafa will establish a comprehensive manufacturing platform for cell therapies, encompassing process development and GMP manufacturing. The AMT designation opens up greater opportunities to leverage this cutting-edge technology, accelerating program development. We will collaborate with innovators including academia and startups, to efficiently bring cell therapy innovations to life.”
This designation will have no impact on the Astellas financial forecasts for the current fiscal year ending March 31, 2026.
About Maholo
Maholo is an experimental humanoid robot with dual arms, specifically designed for life science research, developed by the Robotic Biology Institute (RBI), a subsidiary of YASKAWA Electric. Learn more about Maholo platform by watching this video: www.youtube.com/watch?v=nKQeJPj1UZo
About Cellafa Bioscience
Cellafa is an innovative joint venture that integrates Astellas' extensive regenerative medicine expertise with YASKAWA Electric’s advanced robotics and AI technologies. It creates a state-of-the-art cell therapy manufacturing platform aimed at developing robust manufacturing processes with high efficiency. Learn more at https://cellafa.com
About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com.
Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.
Contacts for inquiries or additional information:
Astellas Pharma Inc.
Corporate Communications
+81-3-3244-3201
References:
U.S. FDA Guidance document: Advanced Manufacturing Technologies Designation Program at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/advanced-manufacturing-technologies-designation-program. Last accessed December 18, 2025.
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