Emergent BioSolutions Inc., world-renowned as a bioterrorism expert, is also utilizing its contract development and manufacturing organization (CDMO) status to help quash the coronavirus disease COVID-19.
“For 22 years, Emergent has focused on products and services that address serious public health threats, such as biological and chemical warfare agents, emerging infectious diseases, and opioid overdoses,” said Sean Kirk, executive vice president of manufacturing and technical operations at Emergent.
“Like these threats,” said Kirk, “the current COVID-19 challenge is complex, which requires a multi-faceted response. Emergent is committed to advancing solutions to respond to the COVID-19 pandemic.”
Emergent manufactures its own products, many of which the federal government buys and stockpiles in preparation for an attack or infectious disease outbreak.
At the same time, the company operates a CDMO business to help other drugmakers develop and manufacture products, and recently signed on to provide such services to two companies, each working on experimental oral vaccine candidates for COVID-19.
As part of its CDMO’s integrated network, Emergent also is marshaling resources from its Bayview facility in Baltimore, Md., which is designated as a Center for Innovation in Advanced Development and Manufacturing (CIADM) by the U.S. Department of Health and Human Services (HHS).
CIADMs are part of a national strategy recommended in the August 2010 Public Health Emergency Medical Countermeasures Enterprise Review, which found that the nation needed a nimble, flexible capacity to produce medical countermeasures rapidly for any threat, known or unknown, including a novel, naturally occurring emerging infectious disease, according to HHS.
“Emergent’s CIADM is a result of a public-private partnership with the Biomedical Advanced Research and Development Authority (BARDA) at HHS,” according to Kirk, who said Emergent is “entrusted to play a role in public health emergencies, and we take this responsibility seriously.”
Kirk said that Emergent and BARDA co-invested to build the state-of-the-art facility, which is designed for large-scale manufacturing of medical countermeasures during public health emergencies.
“Our CIADM has the capacity to produce hundreds of millions of doses of vaccine based upon the platform technology being leveraged,” wrote Kirk. “That capability encompasses clinical scale production meant to get vaccine candidates quickly into the clinic and, in parallel, the scaleup to commercial volumes necessary for the vaccine to help prevent the disease in people.”
Since its designation as CIADM in 2012, Emergent has responded to U.S. government task orders to develop therapeutics for viral hemorrhagic fevers, including Ebola, and a Zika vaccine, according to his post.
Currently, Emergent is working on vaccines to address the COVID-19 pandemic in separate collaborations with Novavax Inc., announced on March 10 and most recently with Vaxart Inc., announced on March 18.
“We rapidly deployed the capabilities, capacities and expertise of our Bayview CIADM and continue to be in active discussions with multiple fellow innovators, ranging from small to large pharmaceutical and biotech companies, to offer our CDMO services, specifically our Drug Substance manufacturing capability at the CIADM, as a response,” according to Kirk.
Under terms of the agreement with the Nasdaq-traded Vaxart, a clinical-stage biotechnology company, Emergent will provide development services out of its Gaithersburg, Md., location and manufacture drug substance at its CIADM facility in Baltimore for COVID-19.
Development services will begin immediately, and upon Vaxart’s election, Emergent will produce clinical material that’s expected to enable Vaxart to initiate a Phase 1 clinical study anticipated early in the second half of 2020.
“Emergent is pleased to deploy our nimble CDMO expertise to support fellow innovators, like Vaxart, and advance an experimental COVID-19 vaccine candidate,” said Syed Husain, senior vice president and CDMO business unit head at Emergent BioSolutions. “We look forward to applying our broad molecule-to-market services, including our ability to work with a multitude of delivery systems, execute under expedited timelines, and meet Vaxart’s potential need for future scalability and large-scale capacity for commercial quantities.”
Since identifying the novel coronavirus sequence early this year — which Kirk said is the first step to developing an appropriate vaccine — companies like Emergent have been working diligently to advance solutions for COVID-19.
“Fortunately, we have a multi-faceted approach and are using our decades-long development and manufacturing capabilities in vaccines and plasma-derived treatments to quickly advance solutions,” Kirk wrote.
Emergent also is supporting both preclinical testing and phase 1 safety trials for the COVID-19 vaccine candidate being developed by Novavax, another Nasdaq-traded, clinical-stage biotechnology company.
U.S. Rep. David Trone (D-MD) this week commended Emergent for its efforts.
“Today I spoke with @emergentbiosolu about their vaccine and therapeutic developments to respond to #COVID19,” Rep. Trone tweeted on March 17. My background is in business. I know the importance of working with companies like @emergentbiosolu to help solve this public health crisis. Let’s all work together.”
In its financial results for the quarter and year ended Dec. 31, 2019, Emergent reported on Feb. 20 that its CDMO services brought in $80 million, or 7.2 percent of total revenue.
Kirk said Emergent is especially proud and thankful to its dedicated employees, who are “getting the job done as expeditiously as possible to make a positive impact on this pandemic.”
Emergent, he wrote in his posting, is “focused on finding solutions to beat this pandemic.”