Fujifilm Biotechnologies has highlighted progress at its Holly Springs, North Carolina manufacturing footprint as part of broader capacity buildouts for cell culture drug substance and product. The company said its commercial-scale cell culture facility was selected under FDA’s PreCheck Pilot Program, intended to strengthen U.S. pharmaceutical manufacturing capabilities. Fujifilm initially invested $2 billion to create a biomanufacturing site with eight 20,000 L mammalian cell culture bioreactors and later announced an additional $1.2 billion plan to add eight more by 2028. The program includes an expanded workforce expected to grow from about 800 to 1,400 during the second phase. The article also notes that argenx has agreed to manufacture drug substance for efgartigimod alfa-fcab (Vyvgart) and Vyvgart Hytrulo in the second phase. Separate from scale-up, Fujifilm marked the opening of a quality control laboratory in Hillerød, Denmark, and described investments in viral safety testing, potency capacity, and laboratory information management system harmonization. For CDMO customers, the updates map directly to priorities around release testing throughput, data integrity, and risk-managed scaling—key constraints for late-stage programs moving from clinical supply toward commercial readiness.