CPhI Online

- Biopharma News

Emergent to manufacture Humanigen COVID-19 therapeutic

25 Jan 2021

The CDMO gears up for rapid deployment of its clinical-to-commercial manufacturing operations for its seventh collaboration to help deliver COVID-19 treatments

Emergent BioSolutions has signed up to provide Humanigen with contract development and manufacturing (CDMO) services to accelerate the drug product manufacturing of lenzilumab, a monoclonal antibody designed to prevent and treat an immune hyper-response called 'cytokine storm'.

Emergent will provide access to manufacturing capacity reserved for and provided by the US government under Humanigen’s Cooperative Research and Development Agreement with the Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in collaboration with BARDA.

Lenzilumab is currently in a Phase III clinical trial evaluating patients hospitalized with COVID-19. Humanigen intends to file for emergency use authorization (EUA) in the first quarter of 2021.

Emergent will provide its integrated CDMO services for the manufacturing of drug product batches to support Humanigen’s efforts to increase the supply of lenzilumab in anticipation of a potential EUA beginning in the first quarter of 2021, including the use of a new state-of-the-art flex fill line at Emergent’s Baltimore, MD (Camden) drug product manufacturing facility.

This newly expanded facility was built to provide increased capacity and flexibility to support companies in need of clinical and commercial manufacturing capabilities.

The parties intend to negotiate a commercial manufacturing services agreement that could include future fill batches for a biologics license application.

For Emergent, this agreement follows and is in addition to the public-private CDMO partnership between Emergent and BARDA, announced in June 2020, to pave the way for high-priority innovators leveraging reserved capacity at their Drug Substance and Drug Product facilities.

This agreement also marks Emergent’s seventh CDMO collaboration with government and industry partners working to deliver COVID-19 vaccine and therapeutic solutions.

Read More

Related Content