J&J hits snag as COVID-19 vaccine contractor failed quality standards
US healthcare giant Johnson & Johnson (NYSE: JNJ) has revealed the contract manufacturer for the COVID-10 vaccine developed by its subsidiary Janssen has failed on quality.
One batch of drug substance has been identified that did not meet quality standards at Emergent BioSolutions, a site not yet authorized to manufacture drug substance for the firm’s COVID-19 vaccine.
In a news release, J&J said quality control checks had flagged the problem before the problematic batch advanced to the filling and finishing stages of its manufacturing process. It said the issue "was identified and addressed with Emergent," adding that it also informed the US Food and Drug Administration.
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