Fujifilm Cellular Dynamics has opened its new headquarters and iPSC development and manufacturing facility in its Madison home. The new site is expected to quadruple the capacity for the company’s iPSC-based research products and services manufacturing footprint and expand capabilities across Fujifilm Cellular Dynamics’ research product portfolio. With an eye toward future demand for contract manufacturing of cell therapy products, the facility is designed to be scalable to accommodate a wide range of processes, from investigational drug manufacturing to commercial production.

The site will expand manufacturing of the company's iPSC-derived iCell product lines, which are increasingly leveraged for New Approach Methods (NAMs) in drug discovery.

Toshihisa Iida, Director, Corporate Vice President, General Manager–Life Sciences Strategy Headquarters and Bio CDMO Division, Fujifilm Corporation, Japan, said, "Completion of this facility comes at a critical time in the iPSC field, where Fujifilm Cellular Dynamics has been setting industry standards for more than 20 years. This new facility enables us to respond to growing demand from pharmaceutical companies, research institutions, and academia engaged in new drug research and development, further delivering on our commitment to the development of life-changing medical treatments and to the people who will benefit from them.”

In recent years, regulatory guidance in the US and Europe has heightened interest in transitioning away from animal testing and toward NAMs. Against this backdrop, the use of iPS cell-derived differentiated cells, which more accurately reproduce human biological functions, has been increasingly adopted in the evaluation of efficacy and safety at the preclinical stage of drug development.

As one part of a previously announced USD 200 million strategic investment by Fujifilm, the 175,000-square-foot building integrates state-of-the-art capabilities—such as cell culture manufacturing laboratories, process development laboratories, and a Center of Excellence (CoE) for gene editing—that support both research-grade iPSC products and development services for partners developing next-generation cell therapies.

Tomoyuki Hasegawa, President and CEO, Fujifilm Cellular Dynamics, said, “The opening of this facility is an exciting milestone for Fujifilm Cellular Dynamics and represents a crucial next step for scaling the infrastructure needed to support the next generation of iPSC-based research and therapeutics in the US. By expanding our development and manufacturing capabilities, we can better support partners working to translate stem cell science into real clinical impact. Our research portfolio additionally supports drug discovery across all therapeutic modalities, thus truly embodying our ‘Partners for Life’ brand.”

The expanded capacity will advance development, manufacturing, and commercialisation efforts across Fujifilm Cellular Dynamics’ portfolio.

Delara Motlagh, COO, Fujifilm Cellular Dynamics, said, “This facility reflects our commitment to reinforcing Madison’s position as a global center for stem cell innovation. The expanded footprint highlights the strength of the region’s biotechnology ecosystem while advancing regenerative medicine by supporting customers worldwide. We are a truly global company, headquartered in Madison.”