Under the agreement, FDB will provide drug substance manufacturing of efgartigimod at its large-scale biomanufacturing facility in Hillerød, Denmark
FDB agrees to manufacture efgartigimod. (Credit: Julia Koblitz on Unsplash)
Fujifilm’s subsidiary FUJIFILM Diosynth Biotechnologies (FDB) has signed an agreement with Dutch biotechnology company Argenx to manufacture efgartigimod.
Efgartigimod is a monoclonal antibody (mAb) fragment that targets the neonatal Fc receptor (FcRn) in patients with severe autoimmune disease.
Under the agreement, FDB will provide drug substance manufacturing of efgartigimod at its large-scale biomanufacturing facility in Hillerød, Denmark.
FUJIFILM Diosynth Biotechnologies Denmark chief operating officer Lars Petersen said: “We are delighted to partner with Argenx and contribute with our expertise and technologies in bringing this important therapy to patients.
“This collaboration underscores our employees’ commitment and ability to successfully onboard new programmes and to provide a well-established and strong ecosystem to manufacture therapeutic antibodies for commercial use at a large scale.”
Efgartigimod is approved in the US and Europe to treat adults with generalised myasthenia gravis (gMG), who are anti-acetylcholine receptor (AChR) antibody positive.
gMG is a chronic autoimmune, neuromuscular disease that causes weakness in the skeletal muscles that deteriorates with activity and improves with rest.
The drug is also approved in Japan to treat adults with gMG who do not have a sufficient response to steroids or non-steroidal immunosuppressive therapies.
It is currently being studied for the treatment of other severe autoimmune diseases known to be mediated by disease-causing immunoglobulin G autoantibodies.
Argenx technical operations global head Filip Borgions said: “We are happy to partner with FUJIFILM Diosynth Biotechnologies to expand our large-scale manufacturing capacity for efgartigimod in our pursuit to bring this innovative treatment to patients in need around the world.”
In June this year, Fujifilm announced a $1.6bn investment to expand the cell culture manufacturing services at FDB.
Earlier this month, the company announced plans to build its first Bio-CDMO facility in the country, in Toyama City, to expand business in the Asian market.
The new Bio-CDMO facility will manufacture biopharmaceuticals at normal times, and mRNA and genetically-engineered protein vaccines during the pandemic.