The contract development and manufacturing organization (CDMO) has been producing both the J&J and AstraZeneca vaccines, but mixed up ingredients from the two, causing the loss of 15 million doses, according to the New York Times.
July 2020 saw Emergent sign off on a deal with J&J for contract development and manufacturing services for its COVID-19 vaccine, with that partnership set to run for five years.
Emergent BioSolutions defended its work last Thursday: “There are rigorous quality checks throughout our vaccine manufacturing processes, and through these checks a single batch of drug substance was identified that did not meet specifications and our rigorous quality standards. We isolated this batch and it will be disposed of properly.”
Nevertheless, the Biden administration, on Saturday, put J&J in charge of the Baltimore facility and it moved to stop the plant from making the AstraZeneca vaccine, a shot not yet approved by the US Food and Drug Administration (FDA).
'The right course'
A White House media briefing yesterday noted that “with assistance from the Health and Human Services (HHS) Department, Johnson & Johnson has taken complete control of the plant. They are going to make the Johnson & Johnson vaccine the only vaccine made in this plant to eliminate the potential for any cross-contamination. This was a decision that HHS made with Johnson & Johnson and AstraZeneca in complete collaboration, and so AstraZeneca also agreed that this was the right course.“
J&J, in a statement on Saturday [April 3], outlined how it was assuming full responsibility regarding the manufacturing of drug substance for its COVID-19 vaccine at the facility. 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.”
The pharma giant added that it continues to work closely with the FDA toward Emergency Use Authorization (EUA) of the Emergent Bayview facility, with it also saying it anticipates delivering nearly 100 million single-shot doses of its COVID-19 jab to the US government by the end of May.
Emergent said yesterday that it welcomes “the additional oversight” that J&J will have in terms of vaccine production at the plant.
"Emergent's top priority continues to be the strengthening of the supply chain for Johnson & Johnson's vitally needed COVID-19 vaccine," said CEO, Robert G Kramer. “We value their partnership and that of the US government to help deliver critically needed COVID-19 vaccines to the American public and globally.”
The CDMO said that it would align with the US government and AstraZeneca's plan to move manufacturing of that vaccine elsewhere.
BARDA funding for biologics production
It also announced that it has received an additional US$23m from Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health & Human Service, to purchase biologics manufacturing equipment specific to the J&J vaccine, for the potential expansion of production of that bulk drug substance into a third suite at its Baltimore Bayview facility.
Emergent currently has nine COVID-19 CDMO partnerships with pharmaceutical and biotech innovators, the US government, non-government organizations for vaccines and therapeutics across a multitude of sites and drug substance, drug product, and development service offerings.