Sanofi together with the Biomedical Advanced Research and Development Authority (BARDA) on Tuesday celebrated the groundbreaking of a new, state-of-the-art formulation and filling facility at Sanofi’s Swiftwater site in Pennsylvania.
The two-story building will be complete with current Good Manufacturing Practices (cGMP) formulation, filling, and support areas. The filler will be capable of filling syringe and vials using isolator barrier technology and single use technology for flexibility. This facility represents one of three significant manufacturing investments made at the site, supported by federal funds, as part of a contract awarded earlier on Dec. 5, 2019 by BARDA to increase domestic production capabilities for recombinant pandemic influenza vaccines.
“This groundbreaking event marks another significant step in our longstanding relationship with BARDA,” Rakesh Kakkar, U.S. head of Vaccine Manufacturing and Supply, Sanofi said. “Past pandemics confirmed that public-private partnerships are key to providing a relevant and quick answer to pandemic situations. Our Swiftwater site, and Sanofi teams globally, have the highest level of expertise in helping to protect people against flu and its complications. We are committed to maintaining continuous efforts to prepare for the next flu pandemic.”
BARDA is part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services.
The Sanofi-BARDA contract supports the clinical development of an adjuvanted recombinant pandemic influenza vaccine that utilizes the same technology as Sanofi’s recombinant quadrivalent influenza vaccine.
The contract also expands the Swiftwater site’s capacity to be a center of excellence for pandemic preparedness by enhancing vaccine manufacturing, adding both recombinant and adjuvant technologies to the current egg-based platform capabilities.
This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50120D00002.