Ajinomoto Bio-Pharma, Humanigen Expand Manufacturing Agreement

Ajinomoto Bio-Pharma Services, a provider of biopharmaceutical contract development and manufacturing services, and Humanigen, a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called cytokine storm with its lead drug candidate lenzilumab, will be expanding their manufacturing agreement for the fill finish supply of lenzilumab, which is one of the few Phase 3 treatment options in development for patients hospitalized with COVID-19. 

Aji Bio-Pharma will assume a key role in simplifying the supply chain efforts for Humanigen by providing drug product aseptic fill finish services at its San Diego facility to support continued clinical trial efforts through potential commercialization. Humanigen is actively enrolling patients in a Phase 3 study in the U.S. and Brazil and preparing for a potential COVID-19 Emergency Use Authorization (EUA) for lenzilumab.

"We are very pleased to be working with Aji Bio-Pharma for the fill finish production of lenzilumab," said Cameron Durrant, chief executive officer, Humanigen. "This partnership allows us to utilize Aji Bio-Pharma's high quality drug product aseptic fill finish services to provide a timely supply of lenzilumab as we near the end of our clinical phase 3 study and prepare for EUA application submission."

Kristin DeFife, senior vice president of operations and site head, Ajinomoto Bio-Pharma Services , said, "We are excited to continue to support Humanigen's efforts to provide this potential therapeutic in the fight against COVID-19. Through this collaboration, we are able to leverage our drug product experience, infrastructure and strong regulatory track record to assist in the efforts that may ultimately help patients struggling with this devastating disease."