In July, Emergent BioSolutions pay $97.5m upfront for Sanofi’s ACAM2000, a vaccinia-based smallpox vaccine that was approved by the US Food and Drug Administration (FDA) in 2007. The acquisition included a 10-year supply contract with the US Government, along with a Sanofi manufacturing facility in Canton, Massachusetts which was being set up to produce the vaccine.
And this week Emergent announced the Canton facility has received FDA approval for the bulk manufacture of ACAM2000 at the Massachusetts site.
“The Canton site was already previously licensed for the ACAM2000 downstream production. The tech transfer for which we received FDA approval involved the upstream portion of the ACAM2000 process,” Emergent spokesperson Miko Neri told Biopharma-Reporter.
Emergent also added a leased fill and finish facility in Rockville, Maryland for the bulk vaccine product. Therefore “transferring the upstream portion previously done in Austria to Canton allows for the full manufacturing process to be done domestically,” we were told.
Vaccine Production
The Canton site is equipped with large-scale bioreactors for cell culture propagation and viral infection for the production of the vaccine.
“The ACAM2000 cell harvest production is based on the expansion of vero cells through static and dynamic cell culture. Following viral infection of the expanded cell culture, the cells are separated from microcarriers using a vibrating screen, mixed, centrifuged and aliquoted,” Neri said.
“Downstream processing involves purification of the cell harvest material using high pressure to disrupt the cells, clarification, concentration and diafiltration, followed by formulation with the addition of excipients, mixing, and aliquoting.”
The production volume of ACAM2000 at the facility is based on the US Centers for Disease Control and Prevention (CDC) contract to supply nine million doses of the vaccine annually. However, it has capacity to quickly increase this to 39 million doses if required.