FUJIFILM Diosynth Biotechnologies, a world leading contract development and manufacturing organization (CDMO) for biologics, viral vaccines and gene therapies, announced that its College Station, Texas, site will support COVID-19 vaccine candidate manufacturing, as part of Operation Warp Speed, a U.S. government program that aims to begin delivering millions of doses of a safe, effective vaccine for COVID-19 to the U.S. population.
The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, issued a task order through the Texas A&M System (TAMUS) Center for Innovation in Advanced Development & Manufacturing (CIADM). The CIADM subcontracts manufacturing to the FUJIFILM Diosynth Biotechnologies owned and operated Flexible Biomanufacturing Facility (FBF) in College Station, Texas. The task order reserves manufacturing capacity in the FBF through the end of 2021. The FBF is one of three manufacturing facilities at FUJIFILM Diosynth Biotechnologies Texas campus.
To enhance vaccine production, the task order will help FUJIFILM Diosynth Biotechnologies accelerate its planned capacity expansion investments in the FBF by several months, now with an anticipated completion by fall 2020.
“Our leading scientists and engineers in College Station are honored to support COVID-19 vaccine manufacturing with the goal of delivering a safe and effective vaccine to the U.S. population,” said Dr. Gerry Farrell, chief operating officer, FUJIFILM Diosynth Biotechnologies, Texas. “We will allocate the reserved capacity based on direction provided by the U.S. government, and similar to our North Carolina site, we expect a portion of the reserved capacity to be allocated to Novavax, Inc. for its NVX-CoV2373 COVID-19 vaccine candidate.”
FUJIFILM Diosynth Biotechnologies announced on July 23 an agreement with Novavax, Inc. to manufacture bulk drug substance for NVX-CoV2373 at its site in Morrisville, North Carolina. The technology transfer from North Carolina to Texas will begin in late 2020 with expanded mass production of the vaccine candidate starting in early 2021.
FUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Teesside, UK, RTP, North Carolina, College Station, Texas and Hillerød, Denmark. FUJIFILM Diosynth Biotechnologies has over thirty years of experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems. The company offers a comprehensive list of services from cell line development using its proprietary pAVEway™ microbial and Apollo™X cell line systems to process development, analytical development, clinical and FDA-approved commercial manufacturing. FUJIFILM Diosynth Biotechnologies is a partnership between FUJIFILM Corporation and Mitsubishi Corporation.