By Peter Loftus 

Emergent BioSolutions Inc. blamed some of the problems at its Baltimore drug plant on having to produce two Covid-19 vaccines at large scale, which the company said strained the capacity of its equipment.

Emergent, a contract drug manufacturer, described some of the problems and its plan to fix them in a letter to the U.S. Food and Drug Administration, responding to the agency's finding of various deficiencies during an April inspection.

A subcommittee of the U.S. House Committee on Oversight and Reform released the April 30 letter on Wednesday, ahead of a hearing by the panel about Emergent.

Emergent was producing a bulk key vaccine ingredient for Johnson & Johnson's Covid-19 vaccine, but a mishap led to the contamination of material that could have yielded up to 15 million doses during January and February.

The contamination came from viral material similar to what was used in the production of AstraZeneca PLC's Covid-19 vaccine at the same plant, according to a memo from the Democratic staff of the House committee to members.

The incident ruined the batch of J&J's vaccine ingredient and led to a halt in production of the J&J vaccine, as well as a decision to relocate production of AstraZeneca's vaccine elsewhere. In addition, J&J took over manufacturing at the Emergent plant.

The FDA's inspection of the Emergent plant found it didn't maintain clean, sanitary conditions and didn't take proper steps to prevent contamination. The inspection found the building and equipment, including refrigerators, weren't big enough to support large-scale manufacturing in a way that would ensure clean conditions.

Emergent, in its April 30 response, said: "The sudden scale-up to full-scale manufacturing activities for two different Covid-19 vaccine drug substances strained the capacity of Emergent's" refrigerators.

The company said it has cleaned and organized them and will purchase additional refrigerators.

The company also said its plant "experienced a dramatic increase in storage and staging demands as the facility operated at full capacity for the first time." The company said it has changed procedures to mitigate the risk of contamination.

Emergent, based in Gaithersburg, Md., said in a statement Wednesday that its role in responding to the Covid-19 pandemic is "unlike any we have confronted before." The company said it is focused on releasing a vaccine ingredient that is currently under evaluation and on resuming vaccine production.

The House committee also released documents showing that Emergent has charged the federal government $27 million a month in reservation fees to be ready to manufacture vaccines.

The government has paid Emergent $271 million of these fees to date, but has partially stopped payment since learning of the contamination, the committee's Democratic staff said in the memo to members.

Emergent Chief Executive Robert Kramer and Executive Chairman Fuad El-Hibri are slated to testify at the hearing, which is scheduled to start at 10:30 a.m. ET.

 

(END) Dow Jones Newswires

May 19, 2021 10:35 ET (14:35 GMT)

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