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Dynavax Hep-B Vax Site Approved

Dynavax's GMP facility in Duesseldorf has been approved for commercial production of hepatitis B surface antigen.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Dynavax Technologies’ GMP manufacturing facility in Duesseldorf, Germany has been approved for the commercial production of hepatitis B surface antigen, a key component of HEPLISAV, the company’s investigational adult hepatitis B vaccine. The approval comes as a result of an upgrade expanding production capacity. With an updated EU GMP manufacturing license in place, Dynavax can meet the initial commercial production demands for the anticipated launch of HEPLISAV, according to a company statement.

Dynavax’s German subsidiary Rhein Biotech has manufactured the hepatitis B surface antigen for HEPLISAV clinical trials in this facility since 2006. The facility upgrade also enhances integrated product development and manufacturing services Rhein Biotech provides to third party partners.

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