15 Sep Fujifilm Cellular Dynamics prepares to open ‘cleanroom’ facility
The company founded 15 years ago by UW-Madison stem cell pioneer James Thomson has reached a new milestone: It is about to open a “cleanroom” facility to produce cells for use in human clinical trials.
Until now, Fujifilm Cellular Dynamics Inc. has produced cells used by pharmaceutical companies and others to develop and screen drugs. The company’s labs in which those cells are grown are, like most labs, clean. But the stakes and requirements are much higher when making cells to be given directly to patients.
FCDI’s new $21 million facility, next to its headquarters at University Research Park, will meet the Food and Drug Administration’s strict standards for Good Manufacturing Practice. With specially filtered air, air-lock entry doors, gowns, gloves and masks worn by workers, and with other provisions, the space will be at least 1,000 times cleaner than a regular lab, company officials said.