www.fdanews.com/articles/199227-thermo-fisher-to-help-manufacture-humanigens-covid-19-therapeutic-lenzilumab
Thermo Fisher to Help Manufacture Humanigen's COVID-19 Therapeutic Lenzilumab
September 25, 2020
Humanigen has teamed up with Massachusetts-based Thermo Fisher Scientific, which will help manufacture the drug substance for Humanigen’s COVID-19 monoclonal antibody lenzilumab.
The partnership is intended to scale up commercial production efforts in advance of a potential Emergency Use Authorization (EUA) from the FDA in 2020 and a subsequent approval. Thermo Fischer expects to begin commercial-scale production of the lenzilumab bulk drug substance before the end of the year.
Lenzilumab is currently in phase 3 testing in the U.S. for prevention of cytokine storms in COVID-19 patients.