Emergent BioSolutions Provides Mfg Updates for COVID-19 VaccinesBy
Emergent BioSolutions, a Gaithersburg, Maryland-based specialty biopharmaceutical company and contract manufacturer, has provided updates on the contract manufacturing of two COVID-19 vaccines respectively from Johnson & Johnson (J&J) and AstraZeneca. The update followed manufacturing issues that arose at Emergent’s plant in Baltimore, Maryland.
Emergent received a contract modification to increase its original task order with the US government by $23 million. The $23 million will be used for the purchase of biologics manufacturing equipment specific to J&J’s COVID-19 vaccine for the potential expansion of manufacturing of J&J’s vaccine bulk drug substance into a third suite of Emergent’s Bayview facility in Baltimore, Maryland.
J&J issued a statement last week (March 31, 2021) regarding a manufacturing issue of its COVID-19 vaccine at Emergent’s Bayview facility stating it is continuing to work with the US Food and Drug Administration and Emergent toward the emergency use authorization of the Emergent’s Bayview facility. J&J is providing additional experts in manufacturing, technical operations, and quality to be on site at Emergent to supervise, direct, and support all manufacturing of its COVID-19 vaccine.
“Emergent’s top priority continues to be the strengthening of the supply chain for Johnson & Johnson’s vitally needed COVID-19 vaccine,” said Robert G. Kramer, President and Chief Executive Officer of Emergent in an April 6, 2021 statement. “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.”
Additionally, Emergent is aligning with the US government and AstraZeneca on a mutually agreed ramp-down of manufacturing of AstraZeneca’s COVID-19 vaccine bulk drug substance at Emergent’s Baltimore facility. AstraZeneca plans to relocate the manufacturing of its COVID-19 vaccine from the facility and is working with the US government to identify an alternative location for the domestic drug-substance production of its COVID-19 vaccine.
AstraZeneca is currently progressing submission to the US Food and Drug Administration for emergency use authorization of the vaccine.
Emergent has nine COVID-19 CDMO partnerships with bio/pharmaceutical companies, the US government, and non-government organizations for vaccines and therapeutics across multiple sites for drug-substance, drug-product, and development services.