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Friday, May 7th, 2021

Emergent BioSolutions on track to meet all COVID-19 vaccine manufacturing commitments

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Emergent BioSolutions Inc. reported this week that it is on schedule to meet all manufacturing commitments related to COVID-19 vaccines, and that the Biomedical Advanced Research and Development Authority (BARDA) has increased its original task order by $23 million.

The funding injection from BARDA will be used to purchase additional biologics manufacturing equipment to boost capacity for Johnson and Johnson’s COVID-19 vaccine. Emergent’s Baltimore Bayview facility could be expanded to include a third suite for that manufacturing.

“Emergent is actively working with the U.S. government to fulfill its policy objectives consistent with the Center for Innovation in Advanced Development and Manufacturing (CIADM) that was put in place under the Obama-Biden Administration in 2012,” Robert Kramer, president and CEO of Emergent, said in an April 4 statement. “This unique public-private partnership has been a key element in our ability to quickly scale up to produce COVID-19 vaccines at a current rate of more than one billion dose-equivalents annually.”

At the same time, the company said that Emergent, AstraZeneca and the U.S. government are likely to reach a mutual agreement to pare down manufacturing of the AstraZeneca COVID-19 vaccine bulk drug substance. 

Last week Kramer told CNBC that one batch of vaccine product for Johnson & Johnson was determined to be inconsistent with the product specifications of both Emergent and J&J and was subsequently pulled aside to ensure it would not be processed further. Kramer noted that Emergent’s quality systems caught the issue as designed and the company was able to move forward on continuing production.

Johnson & Johnson said it is adding dedicated leaders for operations and quality, and significantly increasing the number of manufacturing, quality and technical operations personnel to work with the company specialists already at Emergent.

“Emergent’s top priority continues to be the strengthening of the supply chain for Johnson & Johnson’s vitally needed COVID-19 vaccine,” added Kramer. “We have been working closely with Johnson & Johnson and welcome the additional oversight and support at our Bayview facility, including increased and final sign-off of manufacturing of its bulk drug substance and supervision and direction of all Johnson & Johnson critical manufacturing operations.”

Emergent said it continues to operate in compliance with U.S. Food and Drug Administration (FDA) regulatory standards and all other regulatory authorities. 

Under the existing CIADM agreement, Emergent has been able to expand manufacturing capacity and allowed the government to use reserved capacity for production of COVID-19 vaccines and therapeutics, in accordance with its policy objectives. Emergent itself has nine partnerships with public and private entities regarding COVID-19 vaccines and therapeutics.