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Biopharmaceutical Development and GMP Manufacturing: Preclinical to Commercial Supply August 2015
August 18, 2015
Sponsored by Richter-Helm
Richter-Helm is a dynamic and expanding German biotech company specialized in the development and manufacturing of products derived from microbial expression systems (bacteria and yeasts). Richter-Helm has more than 25 years of experience in process development and GMP-compliant manufacturing of recombinant proteins (e.g., cytokines, antibody fragments), plasmid DNA, and vaccines. With an experienced team of more than 150 employees, Richter-Helm offers tailored solutions to its customers with highest pharmaceutical quality standards confirmed by leading regulatory authorities (the European Medicines Agency (EMA), US Food and Drug Administration, (FDA), Agência Nacional de Vigilância Sanitária (ANVISA), and Ministry of Food and Drug Safety (MFDS)). In addition, Richter-Helm is the platform of its mother companies, Gedeon Richter and Helm AG, for worldwide licensing options and partnerships for codevelopment and marketing of microbial-derived biopharmaceutical projects.
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