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Biopharmaceutical Development and GMP Manufacturing Preclinical to Commercial Supply

机译:生物制药开发和GMP生产在商业供应之前

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Richter-Helm has more than 25 years of experience in the development and good manufacturing practice (GMP)-compliant production of a wide range of biopharmaceuticals, including: recombinant proteins (e.g., cytokines, growth factors, antibody fragments, surface antigens); plasmid DNA; microbial vaccines (e.g., attenuated whole cell vaccines). Customized SolutionsRichter-Helm offers customized solutions for all steps in biopharmaceutical projects through contract development and manufacturing services featuring: GMP state-of-the-art facilities for microbial production; fermentor scale up to 1,500 L; strong expertise in Escherichia coli and yeast (e.g., Pichia); preclinical/clinical trials to market supply at a large scale.
机译:Richter-Helm在开发和生产符合良好生产规范(GMP)的多种生物药物方面拥有25年以上的经验,包括:重组蛋白(例如细胞因子,生长因子,抗体片段,表面抗原);质粒DNA;微生物疫苗(例如减毒全细胞疫苗)。定制的解决方案Richter-Helm通过合同开发和制造服务为生物制药项目的所有步骤提供定制的解决方案,这些解决方案包括:GMP先进的微生物生产设施;发酵罐规模可达1,500 L;在大肠杆菌和酵母菌(例如毕赤酵母)方面有很强的专业知识;临床前/临床试验以大规模供应市场。

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