Texas A&M System And FUJIFILM Diosynth Biotechnologies Receive Federal Contract To Mass Produce A Coronavirus Vaccine Candidate In Early 2021

Screen shot from a Texas A&M university system e-mail.

The Texas A&M university system’s bio-manufacturing center is slated to start manufacturing a coronavirus vaccine candidate early next year.

FUJIFILM Diosynth Biotechnologies (FDB), which is the A&M system’s subcontractor, will mass produce the vaccine candidate developed by Novavax.

While a FUJIFILM plant in North Carolina has been manufacturing the vaccine candidate for clinical trials, bulk production will take place in College Station.

System chancellor John Sharp says the new federal task order is valued at about $265 million dollars.

FDB is accelerating $90 million dollars of expansion projects that began last November with the acquisition of new equipment to address the current pandemic and future emergencies.

President Trump made the announcement Monday afternoon from the FDB plant in North Carolina as part of an update on developing coronavirus vaccines and therapies.

Click below for comments from president Trump’s announcement and an interview with A&M system chancellor John Sharp and WTAW’s Bill Oliver.

Listen to “President Trump announces mass production of a coronavirus vaccine candidate will take place in College Station” on Spreaker.

News release from the Texas A&M system:

The federal government has reserved a high-tech bio-manufacturing center at Texas A&M University 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 the Texas A&M University System Center for Innovation in Advanced Development and Manufacturing (CIADM) through the end of 2021.

FUJIFILM Diosynth Biotechnologies, Texas, (FDB) owns and operates the CIADM’s three facilities as a Texas A&M System subcontractor. FDB is slated to use one of the facilities to mass manufacture 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 facility by helping fund new equipment for use in the current pandemic and future emergencies.

“The CIADM 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 A&M System. It’s a win for FDB. It’s a win for the nation.”

The order supports Operation Warp Speed, which 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 has been awarded $1.6 billion by the federal 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’ 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 for bulk production starting in early 2021.

FDB’s facilities and work force 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 CIADM at Texas A&M was one of three 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.”

News release from FUJIFILM Diosynth Biotechnologies:

FUJIFILM Diosynth Biotechnologies, a world leading contract development and manufacturing organization (CDMO) for biologics, viral vaccines and gene therapies, announced today 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.

For more information, please visit www.fujifilmdiosynth.com

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

FUJIFILM Holdings Corporation, Tokyo, Japan, brings cutting edge solutions to a broad range of global industries by leveraging its depth of knowledge and fundamental technologies developed in its relentless pursuit of innovation. Its proprietary core technologies contribute to the various fields including healthcare, graphic systems, highly functional materials, optical devices, digital imaging and document products. These products and services are based on its extensive portfolio of chemical, mechanical, optical, electronic and imaging technologies. For the year ended March 31, 2020, the company had global revenues of $21 billion, at an exchange rate of 109 yen to the dollar. Fujifilm is committed to responsible environmental stewardship and good corporate citizenship. For more information, please visit: www.fujifilmholdings.com