We provide integrated product development services to enable our partners to bring vaccines and biopharmaceutical products to market.

With over 20 years of experience, we have significant expertise in EU-licensed GMP manufacturing, technology transfer, and project management. We integrate our services into our partners’ programs, from preclinical through clinical development, and to support commercial manufacturing.

Our services have helped our partners bring to market products which include hepatitis B vaccines, combination vaccines, human insulin, human IFNα-2a, and hirudin.

Our 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

We license our proprietary technologies to our partners for worldwide use. One of our leading platforms is our proprietary Hansenula polymorpha yeast expression technology, which currently is used for the commercial manufacturing of several recombinant biopharmaceutical products and vaccines.

In addition, we offer expert immunology services and are equipped to provide GLP testing of preclinical and clinical samples. We have an OECD-GLP Certificate that includes serological testing for characterization of immune responses, analytical testing of biological materials, and cell bank characterization.

For more details, please refer to the following fact sheets:

GMP Product Development Services.

Immunology Services

Cell Banking and Strain Characterization Services

 

For additional information, please contact us at bd(at)rheinbiotech.de

 

Rhein Biotech GmbH
Dynavax Europe
Eichsfelder Strasse 11
D-40595 Düsseldorf

Phone: +49 (0)211 7 58 45 0
Fax: +49 (0)211 7 58 45 130
E-Mail: info(at)rheinbiotech.de