CDMO, CMO, Supplier Roundup in Supporting COVID-19 ProjectsBy
The latest from CDMOs/CMOs and suppliers in COVID-19 projects featuring Emergent BioSolutions, Ajinomoto Bio-Pharma Services, and Just–Evotec.
Just–Evotec Expands US Gov’t Contract for Mfg of mAbs for COVID-19
Just–Evotec Biologics, a technology platform company for the development and manufacture of biologics, and a wholly owned subsidiary of Evotec, has expanded its contract with the US government with an additional $28.6-million award for the production of monoclonal antibodies (mAbs) for use in the development of a treatment and/or prophylaxis for COVID-19.
The US Department of Defense’s (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense is issuing the award in coordination with the Office of the Assistant Secretary of Defense for Health Affairs and the Defense Health Agency.
Under the agreement, the DoD will have access to manufacturing capacity for anti-SARS-CoV-2 mAbs and priority access to future biomanufacturing capacity over a period of seven years in a soon-to-be-completed facility in Redmond, Washington. The agreement represents the continuation of DoD’s collaboration with Just–Evotec Biologics that started in July of 2020.
Formulation Development/Drug-Product Manufacturing
Ajinomoto, Emergent in Mfg Pacts for Humanigen’s COVID-19 Drug
Ajinomoto Bio-Pharma Services and Emergent BioSolutions have formed separate pacts with Humanigen, a Burlingame, California-based biopharmaceutical company, for the manufacturing of Humanigen’s lenzilumab, in Phase III clinical development for treating hospitalized COVID-19 patients. Humanigen intends to file for emergency use authorization (EUA) for the drug in the first quarter of 2021.
Under its agreement, Emergent will manufacture drug-product batches to support Humanigen to increase supply of lenzilumab in anticipation of a potential EUA, The parties intend to negotiate a commercial manufacturing services agreement that could include future fill batches for a biologics license application.
In its agreement, Ajinomoto Bio-Pharma Services will provide drug-product aseptic fill–finish services at its San Diego, California facility to support continued clinical trial efforts through potential commercialization.
Humanigen is enrolling patients in a Phase III study of lenzilumab in the US and Brazil. It is a granulocyte macrophage-colony stimulating factor 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.
Source: Humanigen (Emergent), Humanigen (Ajinomoto), Emergent BioSolutions and Ajinomoto Bio-Pharma Services