FUJIFILM Biotechnologies has expanded its global partnership with immunology company argenx to manufacture the latter’s drug substance for efgartigimod at its Holly Springs site in North Carolina, US, starting in 2028.
This move means argenx is the first announced tenant of FUJIFILM's Phase II expansion at the location.
The expansion will add eight 20,000-litre mammalian cell culture bioreactors, complementing the existing eight reactors of the same capacity.
The expanded agreement will enable argenx to leverage FUJIFILM’s global kojoX network, which aims to provide local-for-local supply by manufacturing closer to patients.
This network offers flexible capacity at both clinical and commercial scale from FUJIFILM’s facilities in the UK, the US, Denmark and the company’s site in Japan.
FUJIFILM Biotechnologies president and CEO Lars Petersen said: “This partnership with argenx marks our first global end-to-end programme in support of a customer utilising our kojoX modular network of facilities. By expanding manufacturing in the US, we will help to meet argenx’ global supply chain needs for efgartigimod.”
Efgartigimod, a monoclonal antibody fragment designed to target the neonatal Fc receptor, is approved globally under the trade names VYVGART and VYVGART Hytrulo.
It is used to treat adults with chronic inflammatory demyelinating polyneuropathy and generalised myasthenia gravis, both of which are chronic autoimmune neuromuscular diseases that lead to significant muscle weakness.
Argenx chief technology innovation officer Filip Borgions said: “Our expanded partnership with FUJIFILM Biotechnologies at its Holly Springs site adds to our existing US manufacturing footprint and further strengthens our global supply chain.
“The kojoX concept enables consistent capabilities across the US and Europe, allowing us to manufacture medicines in the US for American patients while supporting our broader global reach. We are excited to partner with the FUJIFILM Biotechnologies team to unlock the full potential of the kojoX platform.”
In April 2024, Fujifilm announced an investment of $1.2bn (Y177.37bn) in its large-scale cell culture as it expands its North Carolina manufacturing facility, adding 680 jobs to the site by 2031.
