FDA Details GMP Issues at Emergent’s Bayview Plant; Tells J&J to Destroy 60 Million Doses

Emergent BioSolutions’ troubled Bayview, Md., plant, a manufacturing site for Johnson & Johnson’s COVID-19 vaccine, repeatedly failed to seal off a preparation area for vaccine ingredients and allowed production garbage to be carried through the area, leading to contamination, explains Peter Marks, director of FDA’s Center for Biologics Evaluation and Research in a memorandum about the plant’s operations.

The memo offers the most transparent look thus far into why regulators have deemed that a total of about 75 million doses of J&J’s vaccine produced at the plant should be destroyed.

Marks outlines in the June 11 memo details of the plant’s violations of current good manufacturing (GMP) practices, including those that allowed cross-contamination with AstraZeneca’s adenovirus-vectored COVID-19 vaccine, which the plant was also manufacturing.

Certain batches failed to meet the agency’s expectations for quality, and consequently those batches aren’t suitable for use as their safety and effectiveness can’t be assured, Marks said. Additionally, any batches made from a combination of other batches that include batches GMP 5 through 9 are not suitable for use.

“Given this determination, the Agency recommends discarding [batches] GMP 5, 6, 7 and 9,” he said.

Troubles began in September 2020, when the FDA conducted its first pre-Emergency Use Authorization (EUA) site visit at the plant and found crowded manufacturing areas with equipment and supplies, inadequate quality assurance support and several issues related to laboratory controls, according to the memo.

Manufacturing of J&J’s vaccine began at the facility in November. A month later, J&J’s vaccine and AstraZeneca’s vaccine began sharing a common weigh-and-dispense area. With two vaccines being manufactured at the plant, the amount of waste there increased. To handle that, Emergent implemented daily removal of waste by operators who were also working in controlled spaces, the agency found. And medical waste was disposed of in totes along a specific pathway, including through the common weigh-and-dispense area, the agency investigators found.

The FDA returned to the plant for a second pre-EUA site visit in February and discovered many personnel changes and new hires in quality and manufacturing, as well as the need for better documentation and procedures, and consistency with established practices, the memo outlined.

On March 26, J&J subsidiary Janssen notified the agency that it had detected the AstraZeneca COVID-19 vaccine virus in a specific batch, the Janssen COVID-19 Vaccine DS batch 21003600 (GMP8). This batch was produced during a period when Emergent implemented measures to handle increased waste production, the FDA said. The agency said the likely cause was that the bioreactor media was contaminated in the common weigh-and-dispense area through contact with the waste path for materials from the AstraZeneca manufacturing area.

The FDA advised J&J that it should throw out the equivalent of 60 million doses, bringing the total number of doses that cannot be used because of concerns about contamination at the plant to 75 million.

The agency did allow the release of two batches of the J&J vaccine drug substance from the Bayview plant. Emergent welcomed that decision and said it will work with the FDA and J&J to resume production at the plant (DID, June 14).

Read the full memo here: www.fdanews.com/06-14-21-Janssenmemo.pdf. — Suz Redfearn