With global attention fixated on the race to get the COVID-19 vaccine into as many arms as possible, new developments are generating headlines about Emergent BioSolutions, and its Baltimore vaccine manufacturing center.
The Gaithersburg-based company signed on last year to make the Johnson & Johnson vaccine, but the effort is now being overseen by the J&J following a mix-up that ruined 15 million doses.
Emergent may be new to the spotlight when it comes to world headlines, but it has been around. The company was founded in 1998 and went public in 2006. In Baltimore, its presence has been expanding as part of a mix of biotech companies growing a footprint in close proximity to government and medical institutions in Maryland. Long viewed among the vanguard of a local biotech industry that is increasingly making treatments as well as developing new ones in the lab, it is now the source of delays to vaccination in a global pandemic.
Here’s a quick look at the progression from our archives, and other sources:
2009: Buying in Bayview
The company bought a site on Lombard Street near Johns Hopkins Bayview Medical Center in 2009 from MdBio Foundation as it sought to ramp up manufacturing. The building, which sits on city-owned land, changed hands with backing from the city and state government, which contributed $300,000 in incentives. The company was then known for production of its FDA-approved anthrax vaccine, called BioThrax.
2012: Designated by the federal government
The company got an official designation from the U.S. Department of Health and Human Services as a Center for Innovation in Advanced Development and Manufacturing in 2012. There are a lot of official titles in this corner of government-fueled, public-private partnership work. Want another? They’re officially overseen by the Biomedical Advanced Research and Development Authority. In practice, this made Emergent’s facility a key point of productions for vaccines if a surge in supply was needed, as well as medical countermeasures — something that’s important in a pandemic. It became one of three such facilities to get such a designation nationally.
2013: Seeking expansion
The company made moves to get bigger four years after buying the property. It set out to acquire eight more acres of city-owned land next to the Bayview facility in 2013.
2015: Ebola response
In the midst of the Ebola outbreak that originated in West Africa in 2014, Emergent was among the locally rooted companies with vaccine experience that stood at the ready to help. It was sign of the company’s role in a crisis: Emergent secured a contract to manufacture a drug to treat Ebola, and produced its own treatment.
2016: Zika response
The next year, it got funding as the federal government was looking to quickly develop a Zika vaccine, as well. Once again, Emergent signed on to manufacture the drug.
2017: Expansion complete
Emergent opened a bigger version of the Bayview facility in 2017, doubling its size to 112,000 square feet and seeking to expand the local workforce. Later that year, it moved production of the anthrax vaccine to Baltimore after purchasing a “complementary” product from GlaxoSmithKline.
2018: $50 million expansion
The company also opened a second facility in the city, located in Carroll Camden. In 2018, it announced plans to expand the fill and finish plant over three years. Soon, it had another deal to make an under-development vaccine for the Lassa virus.
2020: COVID-19 vaccine agreements
The onset of the COVID-19 pandemic brought a race around the world to develop a vaccine that could end the pandemic. Emergent’s Baltimore facility was once again at the center of this push, as it signed on to manufacture vaccines and treatments being produced by Johnson & Johnson, AstraZeneca, Novavax and Vaxart over a few months in the spring. It was at the forefront among a group of local companies that teamed up in the fight against COVID-19.
February 2021: Scott asks for doses
As regulators appeared to be moving toward approval of the Johnson & Johnson vaccine, Baltimore Mayor Brandon Scott gave a nod to the production facility in the city. He asked J&J to sell 300,000 doses directly to the city in a move toward ensuring equitable distribution.
March 2021: New York Times investigates anthrax vaccine
Increased attention on the company led to a deeper look at its practices. The company landed on the front page of the Sunday edition of The New York Times, as reporters dug into how the federal government’s purchase of anthrax vaccines from the company over the years to prepare for terrorist attacks left fewer resources to respond to the the COVID-19 pandemic when it arrived. Emergent employed lobbying tactics, and generated big profits as a result.
A company spokesperson responded to the Times by saying, “When almost no one else would invest in preparing to protect the American public from grave threats, Emergent did, and the country is better prepared today because of it.”
April 2021: COVID-19 doses ruined
By the end of the month, the Times had a scoop on Emergent that was of the moment, and traced directly to the Baltimore plant. A mix-up of AstraZeneca and J&J ingredients at the facility led to the ruining of 15 million J&J COVID-19 vaccine doses.
“Importantly, the quality control systems worked as designed to detect and isolate this single batch,” the company said. “Discarding a batch of bulk drug substance, while disappointing, does occasionally happen during vaccine manufacturing, which is a complex and multi-step biological process.”
This led to an immediate response by Johnson & Johnson to take over vaccine production at the plant. It also led reporters to dig into the plant’s workings, and they found the problems with procedure at the site traced back further. The Washington Post found an April 2020 inspection report showing issues, and the New York Times uncovered a June warning from a federal official to monitor the plant closely. Meanwhile, the Washington Port reported Monday that company CEO Robert Kramer got a 51% boost in compensation in 2020 as it clocked a 41% increase in revenue.
In response to the Times report, a spokesperson said, “Any allegation that our safety, quality and compliance systems are not working or that we do not take these responsibilities seriously is false.”
The manufacturing issues are having a nationwide impact through the supply chain. Owing to the issues in Baltimore, J&J is scaling back shipments of its vaccine by 86% next week at a time when states are seeking more supply to protect citizens from COVID-19 variants.-30-