About Us :: Dynavax Europe

Rhein Biotech GmbH (Dynavax Europe), headquartered in Düsseldorf, Germany, is a wholly-owned subsidiary of Dynavax Technologies Corporation. Rhein Biotech provides integrated product development services to enable its partners to bring vaccines and biopharmaceutical products to market.

With over 20 years of experience, Rhein Biotech has significant expertise in EU-licensed GMP manufacturing, technology transfer, and project management. The company integrates its services into its partners’ programs, from preclinical through clinical development, and to support commercial manufacturing. These services have helped partners bring to market products which include hepatitis B vaccines, combination vaccines, human insulin, human IFNα-2a, and hirudin.

Rhein Biotech’s integrated product development services include:

Strain, analytical, and process development for a robust industrial and commercial process
GMP production of products to support clinical and commercial use
State-of-the-art EU-licensed GMP facility (10 L and 50 L suites) licensed for both clinical and commercial production
Technology transfer of GMP manufacturing processes and GMP/GLP analytics to partners and CMOs
State-of-the-art R&D and GLP laboratories
QC/QA and product release by Qualified Person
Project management

In addition, Rhein Biotech licenses its proprietary technologies to partners for worldwide use. One of its leading platforms is a proprietary Hansenula polymorpha yeast expression technology, which currently is used for the commercial manufacturing of several recombinant biopharmaceutical products and vaccines. Rhein Biotech also offers expert immunology services and is equipped to provide GLP testing of preclinical and clinical samples. The company has an OECD-GLP Certificate that includes serological testing for characterization of immune responses, analytical testing of biological materials, and cell bank characterization.

For more information about Rhein Biotech’s services, please visit www.rheinbiotech.de.