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ProBioGen
ProBioGen ProBioGen

德國ProBioGen  
德國ProBioGen 成立于1994年.ProBioGen 是一家面向生物制藥行業的細胞系設計、病毒載體以及糖蛋白生產的專業公司。這家德國生物技術公司總部位于柏林。其產品與服務包括開發高產性細胞系、設計來自基本組織的新細胞系、生產用于臨床研究與研發的糖蛋白,以及生產用于體外診斷的病毒載體和抗體。ProBioGen 擁有面向制藥用活性物質(用于臨床研究的測試)的生產授權,并符合了歐盟(歐洲醫藥評價署)和 FDA 推薦的質量標準。經過認證的 cGMP 多用途設備可用于生物制藥活性物質的合同生產。該公司致力于哺乳動物細胞的研究,并將分子生物科學工作者的專業知識與細胞培養技術及處理工程領域的專家經驗結合起來。因此,從候選產品的早期開發階段到后期臨床試驗階段,ProBioGen 全程地為其客戶提供服務。


ProBioGen AG is a renowned Contract Development and Manufacturing Organization (CDMO) and technology provider with focus on cell line engineering, process development (upstream- and downstream process) and GMP manufacturing of biopharmaceuticals. Having almost 20 years of experience in mammalian cell culture, combined with innovative scientific excellence and a strong intellectual property base, we cover the entire drug development value chain, including regulatory support for IND-filing. All of our services and technologies are embedded in a total quality management system to assure compliance with international ISO and GMP standards (EMA/FDA).

Founded in 1994, ProBioGen’s reputation is based on a highly dedicated specialist team who strives for excellence in quality and speed in every project. We are led by a seasoned management team with more than 60 years of experience in the biopharmaceutical industry.

Beyond offering state-of-the-art, fee-for-service-based services from cell line development up to GMP manufacturing, we also developed various innovative technologies for optimized biopharmaceutical manufacturing and analysis.

Our partners esteem us for outstanding service quality, combined with variable project and deal structures, responsiveness and flexibility. We are the partner of choice for biopharmaceutical companies seeking high quality cell line development and manufacturing capabilities since we enable your biopharmaceutical vision.

Our State-of-the-Art Services contain:
Production Cell Line Engineering, including Media Optimization
Upstream and Downstream Process Development
GMP and non-GMP Manufacturing
Analytical Services, including sophisticated Cell-Based Bioassays
 

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