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Thermo Fisher will handle the technical transfer of the lenzilumab bulk drug substance process, with commercial scale production potentially beginning before the end of 2020.
Humanigen, a clinical stage biopharmaceutical company, and Thermo Fisher Scientific announced on Sept. 23, 2020 that they are entering into a strategic collaboration to expand manufacturing capacity for Humanigen’s COVID-19 therapeutic candidate, lenzilumab.
Under the terms of the agreement, Thermo Fisher will handle the technical transfer of the lenzilumab bulk drug substance process, with commercial scale production potentially beginning before the end of 2020, a Humanigen press release said.
“Manufacturing preparation, precision, and expertise are critical as we execute on an aggressive strategy, pending a potential EUA [emergency use authorization] from the FDA, to deliver a COVID-19 therapeutic this winter that has the potential to reduce the risk of ventilation or death and send patients home from the hospital earlier,” said Cameron Durrant, MD, CEO of Humanigen, in the press release. “Thermo Fisher provides biologics manufacturing expertise and scalable capacity to further support our production and growth trajectory."
“Effective therapeutics are an important part of the overall approach to curb the arc of the current pandemic and we are committed to enabling leading therapeutic innovations forward for patients through comprehensive supply chain capabilities and expertise,” added Leon Wyszkowski, president, commercial operations for Thermo Fisher’s pharma services business, in the press release.