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Expansion of partnership broadens argenx' manufacturing capabilities in the U.S., supporting its strategy of local-for-local supply of medicines
HOLLY SPRINGS, N.C.--(BUSINESS WIRE)--FUJIFILM Biotechnologies, a world-leading contract development and manufacturing organization for biologics, vaccines, and advanced therapies, today announced a significant expansion of its global partnership with argenx SE, a global immunology company. As part of the expanded agreement, FUJIFILM Biotechnologies will initiate manufacturing of argenx' drug substance for efgartigimod at the Holly Springs, North Carolina, site in 2028.
argenx is the first announced tenant in FUJIFILM Biotechnologies' Phase II expansion in Holly Springs, which will add 8 x 20,000-liter (L) mammalian cell culture bioreactors to the site's existing 8 x 20,000 reactors.
Efgartigimod is a monoclonal antibody (mAb) fragment that targets the neonatal Fc receptor (FcRn) in patients with severe autoimmune disease. It is approved globally (as VYVGART® and VYVGART® Hytrulo) for the treatment of adults with generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) – both chronic autoimmune neuromuscular diseases characterized by significant muscle weakness.
With the expanded global manufacturing agreement, argenx will benefit from FUJIFILM Biotechnologies' global kojoX™ network, which provides local-for-local supply, manufacturing in close proximity to patients. Through kojoX, the industry's largest interconnected modular network, FUJIFILM Biotechnologies offers flexible capacity at clinical and commercial scales from its manufacturing sites in United States, United Kingdom, Denmark, and FUJIFILM Group's site in Japan.
Posted In: ARGX
