FUJIFILM Diosynth Biotechnologies and the Texas A&M University System Center for Innovation in Advanced Development and Manufacturing have announced that production has begun on two different COVID-19 vaccine candidates in Texas.
These vaccine efforts are supported by the U.S. government to meet Operation Warp Speed goals, the CIADM said.
According to the CIADM, FUJIFILM Diosynth Biotechnologies Texas recently expanded the capacity at its Flexible Biomanufacturing Facility in College Station to accommodate large-scale production of the COVID-19 vaccine candidates.
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FUJIFILM Diosynth Biotechnologies will produce bulk drug substance of NVX CoV2373, Novavax' vaccine candidate, which began phase 3 clinical testing in the United States and Mexico in December 2020, CIADM said.
NVX-CoV2373 is already being manufactured on a commercial scale at the company's plant in Morrisville, North Carolina.
"After several months of intense preparation and hard work, we are ready to produce two vaccine candidates locally here in College Station," Dr. Gerry Farrell, Chief Operating Officer of FUJIFILM Diosynth Biotechnologies Texas, said. "We are pleased to bring our technical expertise and world-class facilities to support the mission of Operation Warp Speed in bringing a safe and effective vaccine to the world."
According to the Texas A&M University System, FUJIFILM Diosynth Biotechnologies owns and operates three facilities built through the CIADM program. As a subcontractor of the Texas A&M System, these facilities can be made available for emergency government use.
In July, the federal government reserved capacity at the College Station facility through the end of 2021 by tapping into an agreement with the CIADM.
FUJIFILM Diosynth Biotechnologies said the company accelerated its planned capacity expansion investments in the facility by several months in order to enhance vaccine production.
The facility is the largest scale-out cell culture manufacturing facility in the United States.
"The Texas A&M System is proud to be part of this unprecedented manufacturing effort," John Sharp, Chancellor of The Texas A&M System, said. "Our partnership with FUJIFILM Diosynth Biotechnologies confirms the importance of the CIADM program for Texas, the nation and the world."
To prepare for mass production of the vaccine candidates, FUJIFILM Diosynth Biotechnologies has added about 260 positions since April 2020, doubling its local workforce.
The company plans to recruit another 50 positions, FUJIFILM Diosynth Biotechnologies said.
"Our team has worked around the clock since July and we're starting to see light at the end of the tunnel," Farrell said. "There is great pride and satisfaction on our team for being part of the solution to the pandemic."
The CIADM contract is with the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
"This is a tremendous responsibility," Dr. W. Jay Treat, Texas A&M's Chief Manufacturing Officer for the CIADM, said. "It's gratifying for us to make a positive contribution in fighting the pandemic."