Dynavax gains EU approval for commercial production of hepatitis B antigen

Published: 10-Dec-2009

Dynavax Technologies, a US biopharmaceutical company, says its GMP manufacturing facility in Duesseldorf, Germany has been approved in the European Union for the commercial production of hepatitis B surface antigen, a key component of Heplisav, the company's investigational adult hepatitis B vaccine.


Dynavax Technologies, a US biopharmaceutical company, says its GMP manufacturing facility in Duesseldorf, Germany has been approved in the European Union 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 expansion of production capacity at the German site. With an updated EU GMP manufacturing licence in place, Dynavax says it will be able to meet the initial commercial production demands for the anticipated launch of Heplisav.

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 the integrated product development and manufacturing services that Rhein Biotech provides to third parties.

Heplisav is an investigational adult hepatitis B vaccine. In a completed pivotal Phase III trial, the company says the product demonstrated increased, rapid protection with fewer doses than current licensed vaccines.

Dynavax has worldwide commercial rights to Heplisav and is developing the vaccine for large, high-value populations that are less responsive to current licensed vaccines, including individuals with chronic kidney disease. Heplisav combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as ISS to enhance the immune response.

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