Emergent BioSolutions Inc. has announced that its Center for Innovation in Advanced Development and Manufacturing (CIADM) has received a task order from the Biomedical Advanced Research and Development Authority (BARDA) valued at up to $21.9 million to develop and manufacture three cGMP lots of a Zika vaccine for use in a Phase 1 clinical trial.
Using a base vaccine candidate provided by BARDA, the company will conduct technology transfer of process materials and information, process and analytical method development, execute small-scale production runs, and perform cGMP cell banking leading to cGMP manufacture of bulk drug substance and final drug product. The task order consists of a 30-month base valued at $17.9 million and includes options that, if executed, will bring the total value to up to $21.9 million.
“Emergent is pleased to partner with BARDA to address the emerging public health threat in Zika,” said Adam Havey, executive vice president and president, biodefense division of Emergent BioSolutions. “We look forward to executing on this task order and working collaboratively with the government in its efforts to help contain this epidemic.” This is the first Zika-related BARDA Task Order awarded to Emergent under the CIADM program.
In 2012, Emergent was designated by the U.S. Department of Health and Human Services (HHS) as a CIADM, which allows the company to contract with the U.S. government through task order requests for requirements such as operational readiness, development and manufacturing of CBRN products, warm base maintenance, surge manufacturing, and workforce development. This Task Order Number HHSO10033003T under contract HHSO100201200004I is funded by BARDA, within the Office of the Assistant Secretary for Preparedness and Response in HHS.