Expanding on a previous collaboration announced in 2022, the agreement will now focus on production of efgartigimod at the contract development and manufacturing organization’s (CDMO) facility in Hillerød, Denmark.
“This agreement marks a milestone for Fujifilm Diosynth Biotechnologies, as Argenx is our first large scale customer to utilize our end-to-end services,” a spokesperson for Fujifilm told BioProcess Insider.
“We have been working with Argenx for two years on efgartigimod drug substance. With this agreement, we will expand our services to include drug products and finished-goods services, aiding in their journey through late-stage clinical trials.”
Efgartigimod, an antibody fragment targeting the neonatal Fc receptor (FcRn), treats patients with severe autoimmune disease. The product is also being evaluated to treat other severe autoimmune diseases known to be mediated by disease-causing immunoglobulin G autoantibodies. It has proved effective in the treatment of gMG, and was approved in the US in 2021, and the EU in 2022 under the name Vyvgart.
“Argenx and many of our customers align with our ‘people-first’ approach. We support our partners in developing life-impacting medicines, and the patient is at the center of everything we do. Trust is an essential ingredient to partnership, and we’ve built a strong relationship and track-record with Argenx with our partnership announced in 2022, and we are pleased to continue this relationship.”
Argenx already has a partnership in place with fellow CDMO Lonza for the production of efgartigimod. Signed in 2015, Lonza and Argenx entered a multi-product license agreement to produce therapeutic antibodies.
The financials of this partnership have not been disclosed.
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