J&J to Take Over Its Product Manufacturing at Emergent Facility

BioPharm International Editors

Following a manufacturing mix-up, J&J will extend its oversight at Emergent’s Maryland facility; AstraZeneca manufacturing to relocate.

At the prompting of the US government, Johnson & Johnson (J&J) will take over responsibility for manufacturing the drug substance for its COVID-19 live viral vector vaccine at Emergent BioSolutions’ Bayview facility in Maryland, following a manufacturing error that led to the loss of 15 million potential doses of the vaccine.

In an April 3, 2021 statement, J&J reported the company “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.”

The news of the change in manufacturing responsibility coincides with an announcement that the Biomedical Advanced Research and Development Authority added $23 million to Emergent BioSolutions’s original task order to purchase manufacturing equipment to expand manufacturing of bulk drug substance of the J&J COVID-19 vaccine into a third suite at the Bayview facility.

In 2012, Emergent BioSolutions became part of a public-private partnership designed to facilitate rapid scale up of needed vaccines during public emergencies. In a press statement, the company noted that “Emergent continues to own the facility and perform its contracts consistent with its obligations to all of its customers and in compliance with the regulatory standards promulgated by the FDA and all other applicable regulatory authorities.”

J&J said the company will work closely with FDA toward Emergency Use Authorization (EUA) of the Emergent Bayview facility.

In addition, manufacturing operations for AstraZeneca’s vaccine candidate AZD1222, another viral vector product, will be moved from the Emergent facility to another location. AstraZeneca said in an April 3, 2021 press statement that it will relocate production of its vaccine as part of the company’s effort “to maximize and accelerate US production of COVID-19 vaccines.” The company is working with the federal authorities to identify an alternate domestic manufacturing site. The AstraZeneca vaccine has not been approved the United States.

Sources:

AstraZeneca

Emergent BioSolutions

Johnson & Johnson