Domestic Capability Building Activity – Onshoring the Manufacturing of Viral Hemorrhagic Fever Vaccine Candidates

The United States Government (USG) has a requirement to expand domestic commercial biopharmaceutical manufacturing capabilities. To meet this need, the USG is initiating an effort to onshore the manufacturing of novel Vesicular Stomatitis Virus (VSV) Delta G based vaccine candidates, expressed in Vero cells, for protection against viral hemorrhagic fever viruses such as Marburg and Ebola Sudan. At present, there is no domestic manufacturing capability for viral hemorrhagic fever vaccines; therefore, it is in the USG’s interest to establish this capability to prepare for and respond to potential viral outbreaks. This effort will involve the technology transfer of the current candidate vaccine production processes (inclusive of bulk drug substance and drug product (formulation, fill/finish)) from their current manufacturing sites, located outside the U.S., to one or more domestic Contract Development and Manufacturing Organizations (CDMOs) located within the US.