- FUJIFILM Biotechnologies will manufacture argenx’ drug substance for efgartigimod at its Holly Springs, North Carolina site from 2028.
- The partnership makes argenx the first announced tenant in the site’s Phase II expansion, which will add 8 x 20,000-litre bioreactors.
FUJIFILM Biotechnologies, a contract development and manufacturing organisation (CDMO), has announced an expansion of its global partnership with immunology company argenx SE. Under the agreement, FUJIFILM Biotechnologies will begin manufacturing efgartigimod drug substance in Holly Springs, North Carolina, in 2028.
The Holly Springs site is undergoing a Phase II expansion that will add 8 x 20,000-litre mammalian cell culture bioreactors to the existing 8 x 20,000-litre reactors. Argenx is the first company to be confirmed as part of this expansion.
Efgartigimod is a monoclonal antibody fragment that targets the neonatal Fc receptor (FcRn) and is approved globally for treating adults with generalised myasthenia gravis and chronic inflammatory demyelinating polyneuropathy. Both conditions are chronic autoimmune neuromuscular diseases associated with muscle weakness.
“This partnership with argenx marks our first global end-to-end program in support of a customer utilizing our kojoX modular network of facilities. By expanding manufacturing in the United States, we will help to meet argenx’ global supply chain needs for efgartigimod.”
Lars Petersen, president and chief executive officer of FUJIFILM Biotechnologies
The expanded collaboration will draw on FUJIFILM Biotechnologies’ kojoX™ modular network, which provides manufacturing capacity across sites in the United States, United Kingdom, Denmark and Japan. The approach is designed to support supply chain resilience and ensure local-for-local production close to patient populations.
