Fujifilm Cellular Dynamics is preparing to open the facility ‘ cleanroom ‘

Formed by UW-Madison stem cell pioneer James Thomson 15 years ago, the company has reached a new landmark: it is about to open a “clean room” facility to produce cells for human clinical trials.
Fujifilm Cellular Dynamics Inc. has created cells for the development and screening of drugs used by pharmaceutical companies and others. Like most laboratories, the laboratories in which these cells are cultivated are smooth. But when allowing cells to be delivered directly to patients, the stakes and requirements are much greater.
The new $21 million plants of FCDI, next to its University Research Park headquarters, will fulfill the rigorous requirements for good manufacturing practice of the Food and Drug Administration. With specially filtered air, air-lock doors, gowns, gloves and masks worn by employees, and other arrangements, the room will be at least 1,000 times cleaner than a standard laboratory, representatives of the business said.
Before closing the building to the public and isolating the region, the business will hold an opening ceremony on Friday.

Shortly afterward, manufacturing could start on four cell kinds for scheduled future tests.

In 2021, he said, he will seek trials for heart disease, cancer, and eye disorders.
For heart disease, it is expected that cardiac cells made by FCDI will be placed on the heart in a graft to try to regenerate the diseased cells of heart failure patients.
For heart disease, it is expected that cardiac cells made by FCDI will be placed on the heart in a graft to try to regenerate the diseased cells of heart failure patients.
Cells based on Thomson’s research
For now, FCDI makes more than a dozen types of cells for pharmaceutical research and has had some 500 customers, including 130 regular customers, mostly in Japan, Europe, and the U.S., Manusos said.

All products are obtained from human-induced pluripotent stem cells or reprogrammed back to their embryonic state by iPS cells, skin or blood cells.

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