An FDA report has illuminated problems at Emergent BioSolution's Baltimore manufacturing site, where the CDMO recently had to scrap up to 15 million Johnson & Johnson COVID-19 vaccine doses over a production error. Thing is, the FDA flagged Emergent for very similar issues almost a year ago to the day.
During an April 2020 inspection of the CDMO's contract testing laboratory, the FDA said Emergent failed to adequately prevent data tampering or deletion, neglected to follow its quality control procedures or put them in writing and, notably, didn't do enough to stop contamination or mix-ups. The FDA published its write-up of the inspection, or the Form 483, this week.
The last item is particularly concerning given the recent J&J snafu. Weeks ago, workers at Emergent's Baltimore plant mixed up the ingredients of J&J and AZ's vaccines, sending a J&J drug substance batch containing up to 15 million doses down the drain, The New York Times first reported.
But Emergent CEO Robert Kramer pushed back on the reporting in an interview with CNBC's Meg Tirrell last week.
"It wasn't the case where an ingredient from one vaccine contaminated or impacted the other," he said on April 1. "It was more simply the fact that one production run, one batch of product, was determined to be inconsistent with our quality specifications."
More recently, NYT reported that some officials suspect an Emergent employee moved between the AstraZeneca and J&J production areas without showering and taking other precautions, resulting in the contamination. An investigation is underway.
It's important to note the FDA's inspection last year took place before Emergent kicked off its COVID-19 work, a company spokesperson said via email. "We have worked and continue to work closely with the federal government in support of the COVID response. These FDA observations were addressed and reviewed in detail with FDA during their recent site visits in September 2020 and February 2021," he added.
At the time of the inspection, the FDA noted that “separate or defined areas to prevent contamination or mix-ups [were] deficient" for materials that needed to be discarded. Specifically, it said Emergent had relegated lots to a reject cage without providing a rationale. The company also failed to affix reject labels to certain scrapped materials, the FDA found.
Meanwhile, the FDA couldn't find records proving that workers in the biochemistry lab had been trained on Emergent's written procedures or test methods.
Things started to sour for Emergent last month, when it became clear that the Baltimore facility had yet to win an FDA manufacturing nod for the J&J shot. Shortly thereafter, reports surfaced about the ruined J&J doses.
"Discarding a batch of bulk drug substance, while disappointing, does occasionally happen during vaccine manufacturing, which is a complex and multi-step biological process," an Emergent spokesperson told Fierce Pharma at the time.
The mix-up prompted the U.S. government to hand control of the CDMO's Baltimore plant to J&J, which has said it's “assuming full responsibility” for drug substance manufacturing there. The New Jersey-based pharma giant says it will bring on quality and operations leaders and "significantly" boost the number of manufacturing experts staffing the site.
Meanwhile, the move has booted out AstraZeneca, which signed Emergent to produce its shot in June. AZ is now working with U.S. officials to track down new manufacturing capacity, the company said last week.