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WHITE PAPERS
PRODUCTS & SERVICES
Development Pipeline
Fill & Finish Services
Production of Plasmid DNA
Production of Recombinant Proteins
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LATEST PRESS RELEASES
September 3, 2013

Richter-Helm Obtains FDA Approval for Commercial Production of a Therapeutic Recombinant Protein

Richter-Helm, a full-service biopharmaceutical contract development and manufacturing organization, has announced that the US Food and Drug Administration has approved...
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Richter-Helm BioTec

Richter-Helm has more than 25 years of experience in the development and GMP-compliant production of recombinant proteins, plasmid DNA and microbial vaccines. With more than 140 employees operating from three sites Richter-Helm is offering customized state of the art solutions for all steps in biopharmaceutical projects via contract development and manufacturing services in GMP facilities for microbial production.

Excellent expertise and tailored service portfolio in the development and manufacture of biopharmaceuticals

Besides a strong expertise in E. coli Richter-Helm successfully produces proteins in yeast (e.g. Pichia pastoris technology). Thus Richter-Helm is the ideal partner for biopharmaceuticals development by offering material from pre-clinical and clinical trials to market supply at a large scale.

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In addition Richter-Helm is the platform of Gedeon-Richter and Helm AG for worldwide licensing options as well as partnerships for co-development and marketing of biopharmaceutical development projects.

Contact

Richter-Helm BioTec GmbH & Co. KG
Suhrenkamp 59
22335 Hamburg
Germany
URL: www.richter-helm-biotec.eu

Contact Person:
Dr. Kai Pohlmeyer
Head of Business Development
Phone: +49.40.55290.430
Email: k.pohlmeyer@richter-helm-biotec.eu

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Top Products from Richter-Helm BioTec


Production of Recombinant Proteins

Production of Plasmid DNA

Production of Vaccines
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Development Pipeline

Currently Richter-Helm has an own pipeline of two biopharmaceuticals projects for the treatment of Osteoporosis and Hepatitis infection, which are ready for partnering.

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Fill & Finish Services

We offer high-end fill and finish manufacturing services for injectables, production services available for R&D, preclinical/toxicological, clinical or commercial batches, together with our reputable parent company Gedeon Richter in our state of the art facility in Debrecen, Hungary.

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BROCHURE AVAILABLE

Production of Plasmid DNA

Development of production strainsEstablishment of MCB/WCBDevelopment of fermentation (1 to 1,500 litres) and down stream processesDevelopment of analytical methodsGMP manufacturing for clinical phase I to IIIGMP commercial manufacturingIn-house QC testing and release 
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BROCHURE AVAILABLE

Production of Recombinant Proteins

Development of production strains (E. coli, Pichia)Optimisation of expression in different systemsEstablishment of MCB/WCBDevelopment of fermentation (1 to 1,500 litres) and down stream processesDevelopment of analytical methods including bioassay developmentValidation of analytical methodsGMP manufacturing for clinical phase I to IIICommercial GMP manufacturingProcess validationIn-house QC testing and releaseStability studies according to ICH 
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BROCHURE AVAILABLE

Production of Vaccines

Richter-Helm has a long lasting experience in the development and manufacturing of microbial vaccines.

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BROCHURE AVAILABLE
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