Fujifilm Cellular Dynamics opens expanded iPSC manufacturing facility in Wisconsin

Fujifilm Cellular Dynamics, a developer and manufacturer of human-induced pluripotent stem cells (iPSCs), has opened a new headquarters and manufacturing facility in Madison, Wisconsin designed to expand capacity for its iPSC-based research products and services and support future cell therapy contract manufacturing.

The 175,000-square-foot facility is part of a previously announced $200 million strategic investment by Fujifilm and integrates cell culture manufacturing laboratories, process development laboratories, and a center of excellence for gene editing, according to the announcement. The site is designed to be scalable to accommodate processes ranging from investigational drug manufacturing to commercial production, the company said.

The facility will expand manufacturing of Fujifilm Cellular Dynamics' iPSC-derived iCell product lines, which are used in new approach methods for drug discovery as an alternative to animal testing. Regulatory guidance in the U.S. and Europe has increased interest in transitioning toward such methods, and iPSC-derived differentiated cells are being increasingly adopted in preclinical efficacy and safety evaluation, according to the company.

Tomoyuki Hasegawa, president and CEO of Fujifilm Cellular Dynamics, said in a statement the expanded development and manufacturing capabilities will better support partners working to translate stem cell science into clinical impact, and that the company's research portfolio supports drug discovery across all therapeutic modalities.

The Madison opening follows a series of recent Fujifilm investments across its broader life sciences network. In the U.S., Fujifilm Biotechnologies' Holly Springs, North Carolina facility — modeled after its large-scale production site in Denmark — is undergoing a $1.2 billion second-phase expansion, adding eight 20,000-liter mammalian cell culture bioreactors, bringing the site's total to 16, as reported by Pharma Manufacturing in March.

Fujifilm has also made a corporate venture investment in Vienna-based Valanx Biotech, whose GoldenSite technology enables site-specific antibody-drug conjugates (ADC), to support Fujifilm's expanding ADC contract development and manufacturing organization capabilities.