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Baltimore facility production was stopped after FDA flagged millions of contaminated doses
Over three months after production at its site was halted by FDA, Emergent’ BioSolutions Inc.’s Bayview manufacturing facility is now set to resume production of Johnson & Jonhson’s Covid-19 vaccine bulk drug substance. This announcement, according to Emergent, follows a thorough review by the organization, weeks of diligent work, and close coordination with J&J and FDA to execute a quality enhancement plan.
Since production was paused at the Baltimore plant, Emergent has been coordinating closely with FDA and J&J to address quality concerns, such as developing and executing an action plan and committing resources to bring operations up to the organization's standards. Emergent expects to continue to work with FDA throughout the manufacturing process to help ensure the strength of the J&J Covid-19 vaccine supply chain.
“The American people should have high expectations of the partners its government chooses to help prepare them for disaster, and we have even higher expectations of ourselves,” says Robert Kramer, Emergent’s CEO. “We have fallen short of those lofty ambitions over the past few months, but resumption of manufacturing is a key milestone, and we are grateful for the opportunity to help bring this global pandemic to an end. We’d like to thank our government partners, as well as Johnson & Johnson, for their support.”