Dynavax gets go-ahead to produce of hepatitis B vaccine component

Dynavax Technologies Corp. announced Dec. 9 that its manufacturing facility in Dusseldorf, Germany, has been approved for the commercial production of hepatitis B surface antigen, a key component of the company's investigational adult hepatitis B vaccine.

With the European Union’s manufacturing license in place, Dynavax can meet the initial commercial production demands for the 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 integrated product development and manufacturing services that Rhein Biotech provides to third party partners.

Heplisav is an investigational adult hepatitis B vaccine. In a completed Phase 3 trial, Heplisav demonstrated increased, rapid protection with fewer doses than current licensed vaccines, Dynavax said in a press release.