CMC Biologics
CMC Biologics 是一家专业的外包生物药品生产开发企业,在丹麦哥本哈根和美国华盛顿州西雅图设有机构。该公司专注于为用于临床前、临床试验和上市的蛋白质疗法的大量化生产和 cGMP 生产提供定制服务。该公司的完全一体化服务包括利用其专有的 CHEF1® 系统开发细胞系、工艺和配方开发以及综合分析测试。CMC Biologics 拥有完全隔离的微生物发酵和哺乳动物细胞培养室,并提供搅拌槽和灌注生产工艺。
CMC Biologics is a results-oriented contract biopharmaceutical manufacturing and development organization (CMO). We focus solely on contract work and are experienced in all phases of development, manufacturing, and quality. We have the ability to provide complete, full-service manufacturing – from DNA to active pharmaceutical ingredient (API) – as well as extensive process, analytical, and formulation development capabilities.
With facilities strategically located in Copenhagen, Denmark and Seattle, Washington (USA), we are equipped to work with clients all over the world. In addition to the broad client base we serve, we also have experience working with global regulatory agencies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).