Emergent BioSolutions is selling off a Baltimore manufacturing site for $30 million to Bora Pharmaceuticals.
Joe Papa“The decision to sell our Camden manufacturing facility is aligned with our multi-year plan to create a customer focused, leaner and more flexible organization, while we improve overall profitability and raise capital to reduce our debt,” Emergent president and CEO Joe Papa wrote in a statement.
In Thursday’s update, Emergent said that its CDMO site has clinical and commercial non-viral aseptic fill/finish services on four fill lines, including lyophilization and formulation development. About 350 Emergent employees will join Bora as part of the sale.
The deal is expected to close in the third quarter.
The company added that the sale is a part of the company’s “streamlining” of its manufacturing network to its Lansing, MI, and Winnipeg sites. Emergent announced in May that the Bayview and Rockville, MD, facilities would be shut down as part of the effort.
With the Camden site sold, Emergent’s exit from the Baltimore area is complete. Emergent’s Bayview facility was marred by a cross-contamination error that cost Johnson & Johnson dozens of millions of doses of their Covid-19 vaccine. The pharmaceutical company notified the FDA in March 2021 that evidence of AstraZeneca’s vaccine virus was found in J&J’s batch.
The FDA had previously raised concerns with the Bayview facility in September 2020, noting “crowded manufacturing areas” and “inadequate quality assurance support,” among other concerns. When regulators returned in January 2021, before J&J’s vaccine was granted emergency use authorization, they flagged that there had been a number of personnel changes to the quality and manufacturing team.
When the FDA returned after J&J raised the prospect of cross-contamination, they found “several objectionable conditions,” including a failure to properly investigate “unexplained discrepancies.”
“These observations indicated that the facility had not been operating in a manner that was in compliance with current good manufacturing practice (cGMP) during the production of the Janssen COVID-19 vaccine,” CBER Director Peter Marks wrote in a June 2021 memo.
Despite J&J receiving emergency use authorization in late February 2021, the first batch of viable vaccine product was not released from Emergent’s Baltimore facility until roughly four months later in June.
This story was corrected to note that the plant involved in the deal was Emergent’s Baltimore-Camden facility, while the one with issues related to Covid-19 vaccine production was Emergent’s Baltimore-Bayview facility.