Rhein Biotech GmbH [Dynavax Europe] offers a comprehensive suite of proprietary production and manufacturing capabilities from generation of a recombinant production organism using proprietary expression systems to process development, manufacturing of clinical samples, manufacturing of commercial products and technology transfer. Dynavax Europe holds a number of patents and patent applications covering technology platforms for recombinant protein production technologies as well as formulation and therapeutic vaccine development.

 

EU GMP / OECD GLP

Rhein Biotech GmbH [Dynavax Europe] holds a GLP and GMP certification status as required in today’s regulatory environment.

 

OECD-GLP Certificate

• Characterization of cell banks
• Analytics of proteins and accompanying substances
• Serological testing for characterization of immune responses
• Analytical testing of biological materials

 

EU-GMP Certificate

• Cell banking
• Aseptic formulation and filling of clinical samples
• Manufacturing of final vaccine bulk
• Biotechnological manufacturing of API

 

Skills and Tools

The core competencies of Rhein Biotech GmbH [Dynavax Europe] in the field of product and process development are backed by a strong set of skills and tools.

• Recombinant protein production using various expressions systems
• Characterization of recombinant production strains
• Protein characterization lipid and polysaccharide chemistry
• Immunology, bioassays, in vitro and in vivo test systems
• Fermentation and down-stream processing know-how (pilot plant)
• Microbiological technologies for production of whole cell- and subunit vaccines
• Production technologies for attenuated and killed viral vaccines
• Novel virus propagation systems
• New adjuvants
• Particle presentation technology for antigen presentation and development of therapeutic vaccines
• Preclinical and clinical sample production
• Commercial manufacturing

 

Product Development

• Strain development
• Process development
• Formulation development
• Analytical development
• Manufacturing (GMP)
• Quality management/quality control
• Preclinical development

 

Facilities and Equipment

• Multi-purpose GMP manufacturing site
• GMP/GLP laboratories
• Cell culture, protein chemistry, microbial and molecular biology laboratories

 

Commercial Activities

• Business development
• Marketing and sales of Supervax, a two-dose hepatitis B vaccine
• Marketing and sales of antigens for diagnostic use
• Licensing-out of established production technologies

 

Hansenula Technology

Rhein Biotech GmbH [Dynavax Europe] has developed a leading technology platform for the production of recombinant products: Hansenula polymorpha yeast expression technology (Hansenula Technology). Hansenula Technology is utilized in a number of commercial biopharmaceutical and biotechnology applications and is acknowledged as the industrial standard for protein production.

Rhein Biotech GmbH [Dynavax Europe] has granted numerous research licenses and commercial licenses for the use of its Hansenula Technology.

 

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