Chime’s in: Humanigen adds Chinese CDMO to support COVID mAb

Humanigen has contracted Chime Biologics to supply its potential COVID-19 therapy lenzilumab outside of the US.

Lenzilumab is in late-stage trials as a treatment for ‘cytokine storm’, an overreaction of the immune system, which has occurred in those suffering from COVID-19.

With planned emergency use authorization (EUA) submissions in the US by the end of May and in the UK and Europe thereafter, Humanigen has increased its manufacturing capacity through a contract with Wuhan, China-based Chime Biologics.

Image: iStock/Valeriya

“Globally there is a shortage of manufacturing capacity and critical material and components,” Cameron Durrant, CEO of Humanigen, told BioProcess Insider. “We have been successful in securing US manufacturing, but we need to add additional manufacturing capacity to meet anticipated global demands and it is sound business practice to look broadly to fulfill production needs, including overseas.”

Humanigen relies solely on third parties for the manufacture of lenzilumab and has deals in place in the US with Catalent, Thermo Fisher, Lonza, and Avid Bioservices for drug substance supply, and with Emergent and Catalent for fill and finish services.

“Chime is the first ex-US CDMO we have contracted with to produce lenzilumab bulk drug substance and finished vials,” Durrant said, adding that while Chime was one of three China-based CDMOs assessed by Humanigen, the deal is not China-focused.

“This is not an agreement to supply lenzilumab in China, rather we needed an ex-US CDMO that meets world-class GMP standards. Chime is a world class CDMO with several products manufactured from its facility in use worldwide. Chime is also using Cytiva (GE) equipment which Humaingen has used previously. This is critical as it makes the transfer of the manufacturing process much easier and more predictable.”

Chime’s facility is intended to supply lenzilumab in the UK, EU, India, and Brazil. The site has 24,000 L of single-use bioreactor capacity, though a planned expansion is set to increase this to 140,000 L.

In the US, Humanigen’s goal is to be able to produce lenzilumab to treat 100,000 patients within the first 12 months of obtaining an EUA. And while estimates on supply outside the US have not been made, Humanigen has said Chime would be willing to commit at least 56,000 L of capacity to the program annually to support ongoing demand.

“Hospitalizations for COVID-19 patients continue at a robust rate. We believe COVID-19 will be similar to the annual flu with cases expected to rise again in the winter of 2021,” said Durrant. “In addition it is imperative that governments prepare for the next pandemic and stockpiling lenzilumab as a variant-agnostic therapeutic agent could support better preparedness for the next wave and the next pandemic.”