Humanigen and Lonza collaborate to expand manufacturing of COVID-19 therapeutic candidate
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Humanigen's proprietary monoclonal antibody may prevent and treat cytokine storm, which is believed to trigger the acute respiratory distress syndrome in severe cases of COVID-19.
Clinical-stage biopharmaceutical company, Humanigen, and Lonza have agreed a strategic collaboration to expand the manufacturing capacity for lenzilumab, currently in Phase III clinical trials for COVID-19, in advance of potential Emergency Use Authorization in 2020 and subsequent commercialization.
The collaboration enables Humanigen to leverage Lonza's monoclonal antibody manufacturing and regulatory expertise.
Lenzilumab represents Humanigen's proprietary Humaneered anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody with the potential to prevent and treat cytokine storm, which is believed to trigger the acute respiratory distress syndrome in severe cases of COVID-19.
This collaboration provides Humanigen with additional capacity for cGMP (current good manufacturing practise) production of lenzilumab with operations intended to start in 2021.
Production of lenzilumab will begin at Lonza's 2,000-L manufacturing facilities at Hayward (CA), USA. Technology transfer is expected to begin in Q3 2020.
The current coronavirus pandemic has highlighted the need for heightened industry collaboration and coordination. In recgnition of this, Jean-Christophe Hyvert, Chief Commercial Officer, Lonza, described the collaboration as an "effort to change the course of this pandemic".
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