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CMO Selection Criteria: Outsourcing GMP Biologicals

机译:CMO选择标准:GMP生物制剂外包

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摘要

Selecting a CMO is critical to biotech biologic drug development. A key factor for selecting a CMO is experience. How do you measure experience? It can be measured in many ways, metrics include: Number of GMP processes developed by the CMO; Number of projects involving your strain; Number of projects involving your product type; GMP production success rate; Number of GMP lots produced. Eurogentec's Biologies Division is specialized in the manufacturing of biopharmaceuticals from microbial sources such as bacteria, yeast, and biosafety level 2 organisms. Eurogentec manufactures in accordance with GMP since 1994.
机译:选择CMO对生物技术生物药物开发至关重要。选择CMO的关键因素是经验。您如何衡量经验?它可以通过多种方式进行衡量,指标包括:CMO开发的GMP流程数量;涉及您的压力的项目数量;与您的产品类型有关的项目数; GMP生产成功率;生产的GMP数量。 Eurogentec的生物学部门专门从事从细菌,酵母和2级生物安全性等微生物来源生产生物药品。自1994年以来,Eurogentec一直按照GMP生产。

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