Novavax has signed an agreement with FUJIFILM Diosynth Biotechnologies (FDB), a US-based contract development and manufacturing organization (CDMO), for the manufacturing of bulk drug substance for NVX-CoV2373, the former’s COVID-19 vaccine candidate.
FUJIFILM Diosynth Biotechnologies’ facility in Morrisville, North Carolina has started production of the first batch of NVX-CoV2373.
The arrangement between the two firms comes under the recent $1.6 billion order bagged by Novavax from the US government as part of Operation Warp Speed program, which is targeting to start delivering millions of doses of a safe, effective vaccine for COVID-19 to the American public.
Novavax said that it is using the funding from Operation Warp Speed program for completing late-stage clinical development, which includes a phase 3 clinical trial, apart from setting up large-scale manufacturing, and for supplying 100 million doses of NVX–CoV2373 beginning as early as late 2020.
Stanley C. Erck – President and CEO of Novavax said: “We are grateful to partner with the team at FUJIFILM Diosynth Biotechnologies to ensure the large-scale manufacture of our COVID-19 vaccine candidate.
“We are committed to working together with unprecedented speed to deliver a vaccine to protect our nation’s population.”
According to the US vaccine development company, NVX-CoV2373 contains a stable, prefusion protein, which is made by using the company’s nanoparticle technology besides including its Matrix–M adjuvant.
Novavax said that the batches of the COVID-19 vaccine candidate produced at the FUJIFILM Diosynth Biotechnologies site in North Carolina will be used in a future phase 3 clinical trial of up to 30,000 subjects which is anticipated to start in the fall of 2020. The phase 3 trial will evaluate the safety and efficacy of the NVX-CoV2373 against the SARS-CoV-2 coronavirus.
Martin Meeson – CEO of FUJIFILM Diosynth Biotechnologies said: “We are delighted to bring our leading technical expertise in baculovirus systems and our proven manufacturing excellence to support Novavax’ response to this global crisis.
“As a critical partner to Novavax, our focus is to advance the delivery of a vaccine that can have a profound impact.”