J&J COVID-19 Vaccine Production Further Disrupted by Subpar Quality at Contract Manufacturer Emergent BioSolutions

J&J COVID-19 Vaccine Production Further Disrupted by Subpar Quality at Contract Manufacturer Emergent BioSolutions

Johnson & Johnson’s (J&J) product plant in the Baltimore, Maryland area was the scene of a disastrous quality error last month, which led to the wastage of millions of vaccine doses as reported by TrialSite recently. Now the U.S. Food and Drug Administration (FDA) recently just halted activity at the plant while the regulatory inspectors investigate the actual error in a bid to perform a root cause analysis. Actually owned and operated by a specialty biotech contract manufacturing firm known as Emergent BioSolutions (EBS.N), they recently shared in a regulatory filing that the FDA halted activity there on April 16. Targeted of the temporary halt, the production of a new drug substance used for the vaccine shot. Of course, Johnson & Johnson is on the record that it would collaborate with both Emergent and the FDA to clear up the situation. Apparently, Johnson & Johnson was placed in charge earlier in April by the federal government after they disclosed the error, which apparently involved a mix-up of ingredients from the AstraZeneca shot, which was also using the facility for contract manufacturing. J&J has some problems as it projected it would deliver 100 mill...

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