HILLEROD, Denmark, Oct. 27, 2022 (GLOBE NEWSWIRE) — FUJIFILM Diosynth Biotechnologies, a world leader in contract development and manufacturing of biologics, vaccines and advanced therapies, today announced an agreement with argenx to manufacture efgartigimod, a monoclonal antibody (mAb ) fragment that targets the neonatal Fc receptor (FcRn) in patients with severe autoimmune disease. Under the terms of the agreement, FUJIFILM Diosynth Biotechnologies will undertake drug substance manufacturing of efgartigimod at its large-scale biomanufacturing facility in Hillerød, Denmark. Terms of the agreement were not disclosed.
Efgartigimod is approved in the United States and Europe for the treatment of adults with generalized myasthenia gravis (gMG) — a chronic autoimmune neuromuscular disease that causes muscle weakness — who are anti-acetylcholine receptor (AChR) antibody positive, and in Japan for the treatment approved by adults with gMG who have an inadequate response to steroids or non-steroidal immunosuppressive therapies. Efgartigimod is also being investigated for the treatment of patients with other serious autoimmune diseases known to be mediated by disease-causing immunoglobulin G autoantibodies and for whom there is a serious unmet medical need.
“We are excited to be collaborating with argenx and using our expertise and technologies to help bring this important therapy to patients,” said Lars Petersen, Chief Operating Officer, FUJIFILM Diosynth Biotechnologies, Denmark. “This collaboration underscores the commitment and ability of our people to successfully launch new programs and provide a well-established and strong ecosystem to produce therapeutic antibodies for commercial use at scale. We are all proud to support efforts to help patients with severe autoimmune diseases.”
“We are pleased to be collaborating with FUJIFILM Diosynth Biotechnologies to expand our large-scale production capacity of efgartigimod to deliver this innovative treatment for…
