Policy & Regulation
Ajinomoto Bio-Pharma Services, Humanigen sign manufacturing agreement
28 May 2020 -

Ajinomoto Bio-Pharma Services, a provider of biopharmaceutical contract development and manufacturing services, has signed a manufacturing agreement with Humanigen Inc, for the fill finish supply of lenzilumab, it was reported on Wednesday.

Lenzilumab is presently being studied in a Phase III clinical trial in adult, hospitalised patients with COVID-19.

According to the terms of the contract, Aji Bio-Pharma is to offer drug product aseptic fill finish services for Humanigen at its San Diego facility. Lenzilumab, Humanigen's proprietary Humaneered anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody, is being administered as part of a United States multi-centre, randomised, placebo-controlled, double-blinded Phase III study for COVID-19 patients. The product neutralises GM-CSF, a key cytokine in the initiation of a cytokine storm.

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