FUJIFILM and argenx Extend Collaboration to U.S. Operations

FUJIFILM Biotechnologies, a top global CDMO for biologics and vaccines, is expanding its partnership with argenx SE, an immunology firm. Under the new agreement, FUJIFILM Biotechnologies will start making the drug substance for argenx’s efgartigimod. This will take place at its Holly Springs, North Carolina, site beginning in 2028.

argenx is the first tenant in FUJIFILM Biotechnologies’ Phase II expansion at Holly Springs. This expansion will add eight more bioreactors. Each one holds 20,000 liters. They will join the eight already on-site.

Efgartigimod is a monoclonal antibody (mAb) fragment. It targets the neonatal Fc receptor (FcRn) to treat severe autoimmune diseases. It is approved worldwide as VYVGART® and VYVGART® Hytrulo. This treatment is for adults with generalized myasthenia gravis (gMG) or chronic inflammatory demyelinating polyneuropathy (CIDP). Both are lasting autoimmune disorders. They cause severe muscle weakness.

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With this new manufacturing deal, argenx SE will tap into FUJIFILM Biotechnologies’ kojoX™ network. This network offers local manufacturing near patient populations. The kojoX network is the biggest modular manufacturing platform in the industry. It offers flexible clinical and commercial capacity from locations in the U.S., the U.K., Denmark, and FUJIFILM Group’s site in Japan.

Petersen noted that the kojoX manufacturing method boosts supply chain resilience. It gives biopharmaceutical partners the speed and flexibility they need. This makes sure important treatments are provided smoothly all over the world.