Progress is being made worldwide to develop and widely deploy COVID-19 vaccines. Expanding the availability of highly effective vaccines is expected to prevent the spread and reduce the severity of COVID-19, resulting in fewer restrictions on activities and reducing social risks such as the growing strain on healthcare systems. The Fujifilm Group is dedicating its talents, resources and technologies to manufacturing drug substance for vaccine candidates to ensure a steady supply of high-quality vaccines as quickly as possible.
In July 2020, FUJIFILM Diosynth Biotechnologies (FDB), a biopharmaceutical contract development and manufacturing organization (CDMO), was tapped by U.S. biotechnology company, Novavax, Inc., to manufacture the antigen of its NVX-CoV2373 COVID-19 recombinant protein vaccine candidate. The antigen in a vaccine is one of the main components that generate an immune response.
In the same month, FDB began production for Novavax’s vaccine candidate at its facility in North Carolina, and its Texas facility began production in December 2020. As part of the U.S. government’s Operation Warp Speed, a public-private initiative for the accelerated development and distribution of COVID-19 vaccines and therapeutic drugs, an agreement was signed to secure a portion of the manufacturing capacity through the end of 2021 at the Texas facility for the Biomedical Advanced Research and Development Authority, an office of the U.S. Department of Health and Human Services. In August 2020, FDB’s facility in the U.K. was tapped to manufacture for Novavax’s vaccine candidate, with production initiating in February 2021.
In Japan, Fujifilm signed an agreement with biotechnology company VLP Therapeutics Japan (VLP Therapeutics) in October 2020 for the manufacture of a COVID-19 vaccine formulation. This COVID-19 vaccine is a lipid nanoparticle formulation containing self-amplifying RNA (a replicon)*1 as the active ingredient. Going forward, the Fujifilm Group will utilize its manufacturing equipment and infrastructure, including the lipid nanoparticle manufacturing equipment at FUJIFILM Toyama Chemical’s 701 Facility, to take on everything from process development to manufacturing for clinical trials of VLP Therapeutics’ COVID-19 vaccine formulations.
Fujifilm Group COVID-19 vaccine development and manufacturing support activities*2
Manufacturing of drug substance for NVX-CoV2373 vaccine candidate developed by US-based Novavax launched in July 2020
Manufacturing of drug substance for NVX-CoV2373 vaccine candidate developed by US-based Novavax launched in December 2020
Manufacturing of drug substance for NVX-CoV2373 vaccine candidate developed by US-based Novavax launched in February 2021
Everything from process development to manufacturing for clinical trials of vaccine formulations developed by VLP Therapeutics Japan
Photo : FUJIFILM Toyama Chemical facility
FUJIFILM Diosynth Biotechnologies plays core role in supporting vaccine manufacturing
FUJIFILM Diosynth Biotechnologies (FDB) has facilities in the U.K., the U.S., and Denmark and provides the contract development and manufacture of various types of biopharmaceuticals including antibody drugs, recombinant protein, gene therapy drugs and vaccines. Biopharmaceuticals are proteins produced in expression systems composed of living organisms such as animal and insect cells as well as microbial systems such as E. coli, to name a few. As an industry leader with many decades of experience, FDB provides comprehensive services including the development of cell lines, process development, clinical and commercial production of biologics, vaccines and viral vectors.
Fujifilm has a legacy of advanced production technology, cultivated in the photographic film field, including technology for maintaining certain conditions during manufacturing and advanced quality control. Application of Fujifilm’s technology to expression technology at FDB has made it possible to increase expression titers and maximize production volumes.
Leveraging these strengths, FDB supports the manufacturing of COVID-19 vaccines and therapeutic candidates thus contributing to the fight against COVID-19.
President and CEO
FUJIFILM Diosynth Biotechnologies
For more than 30 years, FDB has been supporting partner initiatives to provide vaccines and therapeutic drugs to people all over the world.
Our specialized knowledge and capabilities have never been more needed than now during the COVID-19 pandemic.
We are currently putting every effort into supporting the manufacture of Novavax’s COVID-19 vaccine candidate at our facilities in the U.S. and the U.K.
While addressing this global crisis, FDB will lead the efforts of the Fujifilm Group to resolve social issues in the healthcare field, continuing to provide therapeutic drugs that support the lives and health of patients all over the world without interruption.
In July 2020, then U.S. President Donald Trump visited FDB’s North Carolina facility and observed the NVX-CoV2373 drug substance manufacturing equipment, announcing that the U.S. government would contribute roughly US$265 million to support production. In February 2021, U.K. Prime Minister Boris Johnson visited FDB’s U.K. facility. This visit deepened understanding of the technological and production control capabilities of the Fujifilm Group and built anticipation for vaccine availability.
These visits to manufacturing facilities by government leaders showed the social importance of developing vaccines. The Fujifilm Group will continue to work closely with national governments and play a vital role in vaccine production.