德国ProBioGen
德国ProBioGen 成立于1994年.ProBioGen 是一家面向生物制药行业的细胞系设计、病毒载体以及糖蛋白生产的专业公司。这家德国生物技术公司总部位于柏林。其产品与服务包括开发高产性细胞系、设计来自基本组织的新细胞系、生产用于临床研究与研发的糖蛋白,以及生产用于体外诊断的病毒载体和抗体。ProBioGen 拥有面向制药用活性物质(用于临床研究的测试)的生产授权,并符合了欧盟(欧洲医药评价署)和 FDA 推荐的质量标准。经过认证的 cGMP 多用途设备可用于生物制药活性物质的合同生产。该公司致力于哺乳动物细胞的研究,并将分子生物科学工作者的专业知识与细胞培养技术及处理工程领域的专家经验结合起来。因此,从候选产品的早期开发阶段到后期临床试验阶段,ProBioGen 全程地为其客户提供服务。
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