Company Statement: Emergent BioSolutions Statement on Status of Current Manufacturing of COVID-19 Vaccine at Company’s Baltimore Bayview Facility
GAITHERSBURG, Md., April 01, 2021 – At Emergent (NYSE: EBS), safety and quality are our top priorities. Our Bayview facility has been designed and validated to meet all current Good Manufacturing Practices. In addition, there are rigorous quality checks throughout our vaccine manufacturing processes, and through these checks a single batch of drug substance was identified that did not meet specifications and our rigorous quality standards. We isolated this batch and it will be disposed of properly.
Importantly, the quality control systems worked as designed to detect and isolate this single batch.
Discarding a batch of bulk drug substance, while disappointing, does occasionally happen during vaccine manufacturing, which is a complex and multi-step biological process.
We continue to manufacture in support of our customers and the U.S. government, and we remain confident in our ability to meet the FDA requirements. We are very proud of the role the Emergent team is playing in support of the response to COVID-19 and look forward to continuing to do our part to help stem this pandemic.
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Media Contact:
Matt Hartwig
Director, Media Relations
240-760-0551
hartwigm@ebsi.com
Investor Contact:
Robert G. Burrows
Vice President, Investor Relations
240-631-3280
burrowsr@ebsi.com