Findorff added on to Catalent’s existing building and more than doubled its commercial biomanufacturing capacity. A majority of the 77,000 square-foot expansion increased the company’s cell line development and biomanufacturing space. The project houses 29,000 square feet of manufacturing space, 18,000 square feet of support areas, and 30,000 square feet of mechanical/utility spaces.
Catalent uses this state-of-the-art facility to develop, manufacture and analyze pharmaceutical products made from biological sources. The renovated space complies with the requirements of current Good Manufacturing Practice (cGMP) for biological drug substance, as regulated by the Food and Drug Administration (FDA) in the United States (PIC/S Guide to Good Manufacturing Practice). In addition, all of Catalent’s clean rooms are ISO8/Grade D and ISO7/Grade C.