Fujifilm Biotechnologies highlighted a manufacturing milestone tied to the FDA’s PreCheck Pilot Program after the agency selected the company’s commercial-scale cell culture facility in Holly Springs, North Carolina. Fujifilm’s Holly Springs site is part of a broader multi-year buildout, including a $3.2 billion end-to-end biomanufacturing expansion and plans for additional 20,000 L mammalian bioreactors by 2028. The company has cited workforce growth tied to the second phase and described current capabilities including viral safety testing and complex potency release. The site also includes a new quality control laboratory marked by a separate opening in Hillerød, Denmark, expanding QC footprint and supporting digital harmonization via LIMS implementation. A named customer for the second phase was Argenx, which agreed to manufacture drug substance for efgartigimod alfa-fcab and Vyvgart Hytrulo. The PreCheck selection and expansion planning underscore continued demand for large-scale cell culture manufacturing and compliance-ready QC infrastructure.