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Emergent will use its CDMO services to manufacture drug product batches to support the increased supply of the therapeutic candidate in anticipation of a potential emergency use authorization in the first quarter of 2021.
Emergent BioSolutions and Humanigen announced on Jan. 25, 2021 that they are entering into a contract development and manufacturing (CDMO) services agreement to manufacture drug product of lenzilumab, Humanigen’s anti-human granulocyte macrophage-colony stimulating factor monoclonal antibody for the prevention and treatment of an immune hyper-response associated with COVID-19 called the “cytokine storm.”
Through the agreement, Emergent will use its CDMO services to manufacture drug product batches at its Baltimore, MD, drug product manufacturing facility to support the increased supply of the therapeutic candidate in anticipation of a potential emergency use authorization in the first quarter of 2021, Humanigen said in a company press release. The partnership will also offer access to manufacturing capacity reserved for and provided by the US government under Humanigen’s cooperative research and development agreement (CRADA) with the Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense, in collaboration with the Biomedical Advanced Research and Development Authority (BARDA).
“As we continue to advance lenzilumab for patients hospitalized with COVID-19, we are executing on plans to ensure that we have the necessary support for the next phase of our growth. Partnering with leading CDMOs like Emergent BioSolutions to help us build out our manufacturing capacity is a cornerstone to that strategy,” said Cameron Durrant, MD, CEO of Humanigen, in the press release. “The impact of BARDA’s support through our CRADA and its public-private CDMO partnership with Emergent is vital to our progress and bringing innovative solutions for patients with COVID-19.”
“Drug product manufacturing is a hallmark capability of our CDMO services, and we stand ready to harness our expertise to advance lenzilumab, Humanigen’s COVID-19 therapeutic candidate,” added Syed T. Husain, senior vice-president and CDMO business unit head at Emergent BioSolutions, in the press release. “Every second counts in the fight against COVID-19, and we are proud that Humanigen trusts us to rapidly deploy our clinical-to-commercial manufacturing operations to fulfill the urgent need for COVID-19 therapeutic options.”