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FUJIFILM Diosynth Biotechnologies, a world leading contract development and manufacturing organization (CDMO) for biologics, viral vaccines and gene therapies, announce today that its site in Billingham, UK will manufacture antigen component of NVX-CoV2373, Novavax’ COVID-19 vaccine candidate. Billingham plans to begin production of the first batch at beginning of Q1, 2021.
Novavax has signed on August 14 a Heads of Terms (Term Sheet) with the Government of the United Kingdom (UK) for the purchase of 60 million doses of NVX-CoV2373 and a Phase 3 clinical trial to assess the efficacy of the vaccine in the UK population. The Phase 1 data of the Phase ½ clinical trial has already demonstrated to be generally well-tolerated and to elicit robust antibody responses numerically superior to that seen in human convalescent sera.
FUJIFILM Diosynth Biotechnologies expands its collaboration with Novavax to its UK site, in addition to its sites in North Carolina and Texas in the U.S., to ensure stable manufacturing supply of Novavax’ COVID-19 vaccine candidate. FUJIFILM Diosynth Biotechnologies Billingham site has the capacity to produce up to 180 million doses annually, which further boosts the global supply of NVX-CoV2373 for additional markets. Production at the Billingham site will begin in early 2021.
“To change the course of the pandemic, FUJIFILM Diosynth Biotechnologies is excited to expand our partnership with Novavax to manufacture their COVID-19 vaccine candidate at our UK site,” said Paul Found, Chief Operating Officer, FUJIFILM Diosynth Biotechnologies, UK site. “We are honoured to support the UK government and Novavax with the shared goal of delivering a safe and effective vaccine to the British people.”NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.
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
Liza M. Rivera