Ajinomoto Bio-Pharma Services (Aji Bio-Pharma) has expanded a manufacturing agreement with clinical-stage biopharmaceutical company Humanigen for the fill finish supply of the latter’s lead drug candidate, lenzilumab.
The drug candidate is a Phase III treatment option developed for hospitalised Covid-19 patients.
A fully integrated contract development and manufacturing organisation, Aji Bio-Pharma has sites in Belgium, US, Japan and India. It offers comprehensive development, cGMP manufacturing as well as aseptic fill finish services for small, large molecule APIs and intermediates.
According to the agreement, Aji Bio-Pharma will offer Humanigen with drug product aseptic fill finish services at its San Diego facility in the US to support continued clinical trial efforts through potential commercialisation.
Currently, Humanigen is enrolling patients in a Phase III study in the US and Brazil and preparing to submit an application for Covid-19 Emergency Use Authorisation (EUA) of lenzilumab.
Humanigen CEO Cameron Durrant said: “We are very pleased to be working with Aji Bio-Pharma for the fill finish production of lenzilumab.
“This partnership allows us to utilise 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 III study and prepare for EUA application submission.”
Humanigen is currently focused on preventing or reducing the cytokine release syndrome that leads to severe lung dysfunction and ARDS in serious cases of Covid-19.
Ajinomoto Bio-Pharma Services Operations and Site Head senior vice-president Kristin DeFife 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.”
Earlier, Humanigen and EVERSANA have entered a partnership to make available the former’s lead drug candidate, lenzilumab, to hospitalised and hypoxic Covid-19 patients on obtaining approval.