Batches of drug substance from Emergent BioSolutions approved

June 14, 2021

The U.S. Food & Drug Administration (FDA) has authorized two batches of drug substance, manufactured at Emergent BioSolutions’ Bayview facility, to be used in Janssen Pharmaceutical’s single-shot COVID-19 vaccine.

However, the FDA also said it has determined that several other batches are not suitable for use and additional batches are still under review. The agency also said that it is “not yet ready to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility.”

Earlier this year, Johnson & Johnson, parent company of Janssen, said its manufacturing quality-control process identified one batch of drug substance for the COVID-19 vaccine produced at Emergent BioSolutions that did not meet Johnson & Johnson’s standards.

Following an inspection in which it noted a number of quality issues, the U.S. Food and Drug Administration (FDA) told Emergent BioSolutions to pause new production of Johnson & Johnson’s COVID-19 vaccine.

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