NC's COVID-19 Biomanufacturing Prowess Draws Presidential Visit
North Carolina’s global leadership in biomanufacturing has drawn another spotlight with a White House announcement that President Donald Trump will be visiting the Triangle on Monday, July 27, to a company involved in producing COVID-19 vaccine.
The White House scheduled the visit on Thursday, July 23, for the president to hold an event July 27 at the newly expanded Morrisville factory of FUJIFILM Diosynth Biotechnologies (FDB), a world-leading contract development and manufacturing organization (CDMO) for biologics, viral vaccines and gene therapies,
FDB has just completed an expansion of its biomanufacturing facilities in Morrisville, adding about 100 employees as part of a $90 million investment to meet growing demand for biopharmaceuticals. Now, that demand has taken on added significance as the world scrambles to thwart COVID-19.
The Trump visit was announced the same day as a joint announcement by FDB and Maryland drug developer Novavax, on an agreement to manufacture bulk drug substance for NVX-CoV2373, Novavax's COVID-19 vaccine candidate. Actually, FDB's site in Morrisville has already begun production of the first batch of NVX-CoV2373.
Part of "Operation Warp Speed"
This arrangement falls under Novavax's recent $1.6 billion award by the federal government as part of Operation Warp Speed (OWS), a U.S. government program that aims to begin delivering millions of doses of vaccine for COVID-19 to the U.S. population.
The OWS funding is being used by Novavax to complete late-stage clinical development, including a pivotal Phase 3 clinical trial; establish large-scale manufacturing; and deliver 100 million doses of NVX–CoV2373 beginning as early as late 2020.
The companies say NVX-CoV2373 "consists of a stable, prefusion protein made using Novavax's proprietary nanoparticle technology and includes Novavax's proprietary Matrix–M adjuvant." The batches produced at the FDB site in North Carolina "will be used in a future pivotal Phase 3 clinical trial of up to 30,000 subjects." That trial is expected to begin in the next several weeks, to determine the safety and effectiveness of NVX-CoV2373.
"We are grateful to partner with the team at FUJIFILM Diosynth Biotechnologies to ensure the large-scale manufacture of our COVID-19 vaccine candidate," said Stanley C. Erck, Novavax’s president and CEO. "We are committed to working together with unprecedented speed to deliver a vaccine to protect our nation's population."
Martin Meeson, FDB’s CEO, added, "We are delighted to bring our leading technical expertise in baculovirus systems and our proven manufacturing excellence to support Novavax's 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."
Novavax's Phase 1/2 clinical trial of NVX-CoV2373 in 130 healthy participants 18 to 59 years of age began in Australia in May. Novavax says it will announce the Phase 1 data, which will consist of preliminary immunogenicity and safety results, during the first week of August.
The Phase 2 portion to assess immunity, safety, and COVID-19 disease reduction is expected to begin shortly thereafter. The Phase 1/2 clinical trial is being supported by an up-to $388 million funding arrangement with the Coalition for Epidemic Preparedness Innovations.
Biopharmaceuticals are gaining an increasing share of the overall pharmaceuticals market due to the potential of therapies to produce strong results with fewer side effects.
Biopharmaceutical production requires advanced manufacturing technologies and facilities for culturing, separation and purification. Due to the complicated nature of making biopharmaceuticals, an increasing number of pharmaceutical and biotechnology companies are outsourcing process development and manufacturing activities to CDMOs.
In 2016 FDB opened a 62,000-square-foot facility in Morrisville for its bioprocess R&D groups. The building, called the BioProcess Innovation Center, houses the company’s process and analytical R&D, process sciences and stability groups.
FDB is one of NC's many unique, productive partnerships
FDB is a partnership between FUJIFILM Corporation and Mitsubishi Corporation. Besides its Morrisville biomanufacturing site, it has locations in Teesside, UK, College Station, Texas and Hillerød, Denmark. The company has more than 30 years of experience developing and manufacturing 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.
It provides services from cell line development to process development, analytical development, clinical and FDA-approved commercial manufacturing.
FUJIFILM, like other major pharmaceutical and biomanufacturing companies, has expanded production in North Carolina as the state’s workforce training programs targeting these specialized life sciences requirements continue to transform North Carolina's contribution to the sector to one of global leadership.
The parent company, FUJIFILM Holdings Corp. of Tokyo, is a global conglomerate with chemical, mechanical, optical, electronic and imaging technologies that are used in healthcare, graphic systems, materials, optical devices, digital imaging and document products.