Annual Report 2025

Annual Report 2025

Manufacturing and Supply

At argenx, our manufacturing and supply strategy is built for scale, resilience, and speed, reflecting our commitment to move science forward and deliver for patients worldwide. We utilize third-party contract manufacturers who act in accordance with the FDA’s current good manufacturing practices (cGMPs) for the manufacture of drug substances and drug products. We partner with a global network of contract manufacturers who share our standards for quality and innovation, with the goal that every step, from cell bank development to large-scale drug substance production, meets the highest industry benchmarks. Our global supply chain and distribution strategy is to serve patients in region for that region. We work with Lonza teams based in Slough, UK, Portsmouth, U.S., Singapore and Visp, Switzerland for activities relating to the development of cell banks, development of our manufacturing processes and the manufacturing of drug substance, thereby using validated and scalable systems broadly accepted in our industry. In 2022, we started our collaboration with FUJIFILM Diosynth Biotechnologies Denmark ApS (Fujifilm) based in Hillerød, Denmark, for activities relating to the large-scale manufacturing of efgartigimod drug substance. In 2025, we expanded our partnership with Fujifilm to include new manufacturing site in North Carolina, U.S., strengthening our global supply chain and supporting anticipated growth in efgartigimod and pipeline assets.

We use additional contract manufacturers to fill, label, package, store and distribute (investigational) drug products.