Emergent BioSolutions strengthens manufacturing infrastructure with FDA-licensure

By Melissa Fassbender contact

- Last updated on GMT

(Image: iStock/Esben_H)
(Image: iStock/Esben_H)

Related tags: Smallpox

The US Food and Drug Administration (FDA) has approved Emergent BioSolutions’ supplemental Biologics License Application (sBLA) for the manufacture of ACAM2000, the only FDA-licensed smallpox vaccine, as the company looks to expand its CMO services.

The life sciences company and contract manufacturing organization (CMO) acquired the ACAM2000 business from Sanofi last month.

As part of the transaction, the company also acquired a cGMP live viral bulk manufacturing facility in Canton, MA, and a live viral fill/finish manufacturing facility in Rockville, MD.

The company has also assumed a 10-year Centers for Disease Control and Prevention (CDC) contract originally valued at $425m to establish warm base manufacturing of ACAM2000 in the US and deliver doses of ACAM2000 to the Strategic National Stockpile (SNS).

Completed deliveries are expected in 2019, Sean Kirk, SVP manufacturing operations and CMO business unit head at Emergent BioSolutions told Outsourcing-Pharma.com.

Receiving FDA-licensure of the Canton facility for the upstream portion of the ACAM2000 process meets our current commitment under our existing contract with the CDC to maintain domestic capabilities to manufacture a licensed smallpox vaccine​,” Kirk said.

The facility was previously licensed for the downstream portion of the ACAM2000 process, he explained. The most recent licensure “strengthens Emergent’s manufacturing infrastructure and competencies with the addition of bulk viral capability to address public health threats​,” Kirk added.

In addition to manufacturing the smallpox vaccine, the Canton facility also serves as a CMO. Kirk said the facility currently has an existing customer.

Emergent is looking to expand its clientele and offerings, with live viral vaccine manufacturing capabilities, as part of our CMO services and infrastructure​,” he added.

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