FUJIFILM Cellular Dynamics, Inc. (FCDI), a global developer and manufacturer of human induced pluripotent stem cells (iPSC) technologies, will begin operations at its new cGMP-compliant iPSC production facility in Madison, WI on March 4. The new Innovation Facility for Advanced Cell Therapy (i-FACT), will house development and manufacture of iPSCs for therapeutic applications. The i-FACT will enable FCDI to accelerate the development of its own pipeline of regenerative medicine therapies using iPSCs, as well as serve as a Contract Development and Manufacturing Organization (CDMO) of IPSCs and iPSC-derived differentiated cells.

The $21 million, 32,000 sq.-ft. facility features four development labs and three cGMP suites for in-house therapeutic development and for collaboration with other companies. The facility is designed to enable each suite to manufacture a different product to offer scale-up and scale-out biomanufacturing ability to facilitate various batch sizes. A quality department has been established to ensure the accuracy and quality of iPSC therapeutic products developed and manufactured at i-FACT. The facility serves production of high-quality iPS Cells in high efficiency, using FCDI’s iPS Cells reprogramming and differentiation technologies and FUJIFILM Corp.’s advanced technologies such as engineering and image analysis.

“Over the years, FCDI has provided millions of high quality human iPSCs to our partners engaged in life science research,” said Takeshi Yamamoto, CEO, FUJIFILM Cellular Dynamics Inc. “We are excited to begin operations at i-FACT as it signals an expansion of our business into cell therapies. At FCDI, we are fully committed to leveraging the power of human-iPSCs to transform scientific research and revolutionize healthcare.”