Less than one week after forging a vaccine manufacturing agreement with Novavax, FUJIFILM Diosynth Biotechnologies announced its College Station, Texas facility was selected by the federal government to support COVID-19 vaccine candidate manufacturing.
Less than one week after forging a vaccine manufacturing agreement with Novavax, FUJIFILM Diosynth Biotechnologies announced its College Station, Texas facility was selected by the federal government to support COVID-19 vaccine candidate manufacturing.
During a press conference Monday, President Donald Trump issued a task order to reserve the entire facility’s manufacturing capacity for a COVID-19 vaccine candidate at FUJIFILM Diosynth Biotechnologies’ Texas site as part of the federal government’s Operation Warp Speed response to the pandemic. Following the press conference, FUJIFILM said the task order was issued by the Biomedical Advanced Research and Development Authority (BARDA) 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, the company said.
Gerry Farrell, chief operating officer of FUJIFILM Diosynth Biotechnologies in Texas, said the company and its employees are honored to be tasked with supporting the manufacturing of a COVID-19 vaccine.
“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,” Falwell said in a statement.
Last week, FUJIFILM Diosynth Biotechnologies announced an agreement with Novavax, Inc. to manufacture bulk drug substance 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.
The FUJIFILM site in N.C. was visited by Trump on Monday. During that visit, Trump learned more about the vaccine candidate under development by Maryland-based Novavax, NVX-CoV2373, which FUJIFILM is supporting with its manufacturing capabilities. Novavax was one of the companies selected for financial support by Operation Warp Speed. In June, the company secured $1.6 billion in federal funding to support its COVID-19 vaccine development program.
NVX‑CoV2373 consists of a stable, prefusion protein made using its proprietary nanoparticle technology and includes Novavax’s proprietary Matrix‑M adjuvant. The company initiated a Phase I/II trial in May, with preliminary immunogenicity and safety results expected at the end of July. The Phase II portion of the trial, which will assess immunity, safety, and COVID-19 disease reduction is expected to begin thereafter.
