Fujifilm Cellular Dynamics (FCDI), a developer and manufacturer of human-induced pluripotent stem cells (iPSCs), has begun operations of its new cGMP-compliant iPSC production facility in Madison, Wisconsin. FCDI invested JPY 2.5 billion ($21 million) in the facility, which the company will use for its own pipeline of regenerative medicine therapies using iPSCs as well as to provide CDMO services of iPSCs and iPSC-derived differentiated cells.

The facility will house development and manufacture of iPSCs for therapeutic applications. The 32,000-square-foot design features four development laboratories 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, which allows FCDI to manufacture various batch sizes. A quality department has been included for iPSC therapeutic products developed and manufactured at the facility. The facility will produce iPS cells using FCDI’s iPS cells reprogramming and differentiation technologies and Fujifilm Corporation’s technologies such as engineering and image analysis.

FCDI’s internal pipeline focuses on developing off-the-shelf allogeneic cell-therapy candidates in the areas of ocular diseases, including age-related macular degeneration and retinitis pigmentosa, heart failure, immuno-oncology, and Parkinson’s disease. In the field of oncology, Fujifilm has partnered with the US venture-capital firm, Versant, and its new company, Century Therapeutics, with the goal of developing new immunotherapies for cancer using allogeneic iPS cell-derived chimeric antigen receptor (CAR) T cells.

In addition to developing cell therapeutic candidates, FCDI will also continue to manufacture and develop its drug-discovery research products, including iCell and MyCell products, which are used to support drug-discovery research and safety and toxicity testing.

Source: Fujifilm Cellular Dynamics