Fujifilm Biotechnologies highlighted recent expansion momentum in U.S. and European operations, including FDA selection of a Holly Springs, North Carolina commercial cell culture facility for the agency’s PreCheck Pilot Program. The move underscores growing scrutiny on process consistency and quality readiness in advanced manufacturing. Fujifilm also disclosed customer-linked scaling plans at Holly Springs, where argenx agreed to manufacture drug substance for efgartigimod alfa-fcab (Vyvgart) and the injectable Vyvgart Hytrulo product. The site’s broader buildout follows the initial phase of a multi-year, multi-bioprocess biomanufacturing investment. In parallel, Fujifilm marked the opening of a quality control laboratory at its Hillerød, Denmark facility, adding viral safety testing capacity and supporting automation and lab information management system harmonization. For CDMOs and biologics developers, these upgrades signal improving throughput and data integrity for release testing and complex cell-based potency workflows.