On Apr. 2, 2020, Emergent BioSolutions announced it had entered into a formal partnership with the U.S. government to expedite development of a plasma-derived therapy for patients with coronavirus disease 2019 (COVID-19). Emergent had received $14.5 million from the BARDA in support of its COVID-HIG program, one of two hyperimmune development programs announced by Emergent in March.

COVID-HIG was a candidate human hyperimmune product being developed as a potential treatment for COVID-19 in severe hospitalized patients and high-risk, acute symptomatic patients to prevent progression to severe symptoms. COVID-HIG will be manufactured using plasma donations from people who have recovered from COVID-19 with antibodies to SARS-CoV-2.

Emergent and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), have agreed to incorporate the company’s COVID-HIG product candidate into one of NIAID’s clinical studies for assessment of treatments for COVID-19 once clinical material is available, and the study begins. Emergent has already initiated plasma screening and collection of human plasma with antibodies to SARS-CoV-2 that will be further purified and concentrated through manufacturing of COVID-HIG.

Hyperimmunes are polyclonal antibody therapeutics that are manufactured from plasma and leverage the natural immune response in humans or animals. COVID-HIG has the potential to serve as both a treatment for severe hospitalized patients and protection for at-risk individuals. In parallel and separate from the COVID-HIG development effort with BARDA, COVID-EIG, manufactured from the plasma of immunized horses with antibodies to SARS-CoV-2, will be developed by the company as a potential treatment for severe hospitalized patients.

Emergent’s multi-faceted response to COVID-19 includes the rapid deployment of its molecule-to-market contract development and manufacturing (CDMO) services. The company recently announced collaborations to develop and manufacture two COVID-19 vaccine candidates utilizing its integrated network, which includes its Baltimore Bayview CIADM. The Baltimore Bayview CIADM offers the capacity to produce tens to hundreds of millions of doses of vaccine annually depending on the platform technology used. Emergent continues to be in discussions with fellow innovators about how the company can help advance their development and manufacturing programs.