With $1.6 billion of US government funds in hand, Novavax has contracted CDMO Fujifilm Diosynth Biotechnologies (FDB) to produce Phase III trial material for its COVID-19 vaccine candidate.
Earlier this month, the US government handed Novavax – a firm with no approved products – $1.6 billion to progress the development of its vaccine candidate NVX‑CoV2373 against the novel coronavirus (SARS-CoV-2). Until a $2 billion deal was struck this week with Pfizer/BioNTech, the funding was the largest under the Operation Warp Speed program, aimed at accelerating the development and supply of COVID-19 vaccines.
At the time, Novavax said the money would be used to support upcoming Phase III trials and to establish scale-up manufacturing capacity to deliver 100 million doses by the end of the year.
Image: iStock/mrdoomits
And now a deal has been signed with contract development and manufacturing organization (CDMO) FDB to produce bulk drug substance for NVX-CoV2373 from its site in Morrisville, North Carolina.
“NVX-CoV2373 consists of a stable, prefusion protein made using Novavax’ proprietary nanoparticle technology and includes Novavax’ proprietary Matrix–M adjuvant,†Novavax said in a statement.
“The batches produced at the FDB site in North Carolina will be utilized in a future pivotal Phase III clinical trial of up to 30,000 subjects which is expected to begin in the fall of 2020 and which will determine the safety and efficacy of NVX-CoV2373.â€
The site in Research Triangle Park offers customers biomanufacturing services and has seen steady investment to increase capabilities and capacity over the past few years. In February, the CDMO broke ground on a $54 million expansion to increase cell culture manufacturing capacity by approximately 25% and microbial capacity by approximately 50% at the site, through the addition of 2,000 L single use cell culture manufacturing trains, cell culture purification suites and new microbial recovery suites.
The Morrisville site will also be subject to an inspection by President Donald Trump himself next week, abcNews reported.
“We are obviously excited to host the president and to take him through what we do here and have him see what is going on in the manufacture of a vaccine like this,†FDB CEO Martin Meeson told the news channel. “To be involved in that is extremely motivating and exciting for the staff here.â€
FDB adds to the increasing amount of vaccine production capacity available to Novavax for the COVID-19 candidate. Fellow CDMO’s AGC Biologics, the Polypeptide Group, and Emergent Biosolutions are also signed up to the NVX-CoV2373 project.