Under the agreement, Chime Biologics will produce lenzilumab bulk drug substance and drug product for Humanigen for commercial sale
Humanigen and Chime Biologics, a contract development and manufacturing organisation (CDMO), have entered into a manufacturing services agreement for Humanigen’s Covid-19 therapeutic candidate lenzilumab.
Under the agreement, Chime Biologics will produce lenzilumab bulk drug substance and drug product for Humanigen for commercial sale after receiving necessary regulatory approvals in regions outside the US, including Europe, the UK, India and Brazil.
Humanigen, a US-based clinical-stage biopharmaceutical company, aims to develop lenzilumab as a therapy for hospitalised, hypoxic Covid-19 patients.
The company said that it held a meeting with the US Food and Drug Administration to discuss the filing of an emergency use authorisation (EUA) for lenzilumab. It plans to submit a EUA application by the end of this month.
Humanigen CEO Cameron Durrant said: “With the recent announcement of the results from the LIVE-AIR Phase 3 clinical trial of lenzilumab, we are pleased to enter into a partnership with Chime to help with our anticipated commercial production of lenzilumab.
“Following a competitive process focused on quality, technical abilities, supply chain and economic criteria we selected Chime as our first foreign CDMO to supply lenzilumab to ex-US markets.”
As per the terms of the agreement, Chime will leverage the modular single-use KuBio (Cytiva) biologics facility in China.
The facility has the cell culture capacity of 24,000L with planned expansion to 140,000L. Chime would commit at least 56,000L for Humanigen manufacture annually.
Technical transfer work has already commenced, and commercial product is scheduled to be available next year.
Chime Biologics CEO Dr. John Zeng said: “We are pleased to have been selected by Humanigen as a manufacturing partner for ex-US supply of lenzilumab.
“Since 2013, Chime Biologics has developed and produced more than 30 products and supplied to over 20 countries from its latest generation single-use facility.
“We are proud of our record for quality, compliance, bioprocessing expertise, and cost effectiveness, and very much look forward to supporting Humanigen in this important programme.”