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CMC Biologics  
CMC Biologics 是一家專業(yè)的外包生物藥品生產(chǎn)開發(fā)企業(yè)，在丹麥哥本哈根和美國華盛頓州西雅圖設(shè)有機(jī)構(gòu)。該公司專注于為用于臨床前、臨床試驗(yàn)和上市的蛋白質(zhì)療法的大量化生產(chǎn)和 cGMP 生產(chǎn)提供定制服務(wù)。該公司的完全一體化服務(wù)包括利用其專有的 CHEF1? 系統(tǒng)開發(fā)細(xì)胞系、工藝和配方開發(fā)以及綜合分析測試。CMC Biologics 擁有完全隔離的微生物發(fā)酵和哺乳動物細(xì)胞培養(yǎng)室，并提供攪拌槽和灌注生產(chǎn)工藝。

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).