COLLEGE STATION, Texas – The federal government has reserved a high-tech bio-manufacturing facility here for mass production of a COVID-19 vaccine as part of a program discussed Monday by President Donald Trump.
The new federal task order is reserving production capacity at one of the College Station facilities to mass manufacture vaccines through the end of 2021.
The order, which supports Operation Warp Speed, is between the federal government and the Texas A&M University System’s Center for Innovation in Advanced Development and Manufacturing (CIADM). The CIADM was developed in response to the H1N1 influenza pandemic.
As a subcontractor to the Texas A&M System, FUJIFILM Diosynth Biotechnologies, Texas, (FDB), owns and operates three facilities built through the CIADM program. They can be tapped for emergency use by the federal government.
FDB is slated to use the reserved capacity at one of the FDB facilities for the COVID-19 vaccine candidate of Novavax, Inc., NVX-CoV2373.
Valued at about $265 million, the task order also will accelerate a planned expansion at the FDB facility by helping fund new equipment for use in the current pandemic and in future emergencies.
“The Texas A&M System is ready to save lives and help protect the country,” said John Sharp, Chancellor of The Texas A&M University System. “This whole project is a triple win. It’s a win for the Texas A&M System. It’s a win for FDB. It’s a win for the nation.”
View a video on the Texas A&M System’s role in the project: https://vimeo.com/442035087
Operation Warp Speed aims to begin delivering millions of doses of COVID-19 vaccines by the end of the year if the U.S. Food and Drug Administration determines candidates are safe and effective.
Novavax is being funded by the government to complete late-stage clinical development, including a pivotal Phase 3 clinical trial; establish large-scale manufacturing; and deliver 100 million doses of NVX‑CoV2373, Novavax’s COVID-19 vaccine candidate.
The FDB plant in North Carolina, where President Trump visited Monday, is already producing the Novavax vaccine candidate for its clinical trials. FDB is slated to transfer the manufacturing process to College Station in late 2020 and start bulk production in early 2021.
FDB’s facilities and workforce in Texas can accommodate multiple vaccine technologies and help expedite the government’s large-scale manufacturing efforts. The manufacturing preparation is being done in parallel with ongoing clinical trials and the FDA’s safety and effectiveness approval process.
FDB calls the facility reserved for Novavax vaccine production its “Flexible BioManufacturing Facility.”
“FUJIFILM Diosynth Biotechnologies is committed to be a partner for life and deliver these much-needed COVID-19 vaccine doses,” said Dr. Gerry Farrell, Chief Operating Officer of FDB in Texas. “We are ready to move swiftly to deliver on multiple vaccine candidates as directed by the U.S. government.”
The Texas A&M System’s CIADM was one of three centers developed in the U.S. in response to the H1N1 influenza pandemic by the Biomedical Advanced Research and Development Agency (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
The task order is an amendment to the CIADM contract between the System and BARDA.
“This validates why the CIADM program was established,” said Dr. W. Jay Treat, Texas A&M’s Chief Manufacturing Officer for the CIADM. “We have state-of-the-art facilities ready to make millions doses of vaccines to meet the critical needs of our citizens.”
About The Texas A&M University System
The Texas A&M University System is one of the largest systems of higher education in the nation with a budget of $6.3 billion. The System is a statewide network of 11 universities; a comprehensive health science center; eight state agencies, including the Texas Division of Emergency Management; and the RELLIS Campus. The Texas A&M System educates more than 151,000 students and makes more than 22 million additional educational contacts through service and outreach programs each year. System-wide, research and development expenditures exceeded $1 billion in FY 2019 and helped drive the state’s economy.
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.
For more information, go to: www.fujifilmdiosynth.com
Novavax, Inc. (Nasdaq:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, with preliminary immunogenicity and safety results expected to be announced during the first week of August. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.