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A CMO's Approach: To Provide World-Class Cell Culture Development and Manufacturing Services

机译:CMO的方法:提供世界一流的细胞培养开发和制造服务

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摘要

Industry leading biologies contract manufacturer Fujifilm Diosynth Biotechnologies located in Research Triangle Park, NIC (formerly Diosynth Biotechnology) and in Billingham, UK (formerly Avecia Biologies) provides third-party contract development andmanufacturing services to the biopharmaceutical industry. Fujifilm Diosynth Biotechnologies has supplied clinical and commercial recombinant proteins produced in cell culture for more than 14 years. We have extensive experience in microbial developmentand manufacturing and equal experience in the cell culture space. Our development experience includes over 30 cell culture processes, of which two-thirds were CHO derived, and over 20 monoclonal antibody programs. In addition, Fujifilm Diosynth has executed four baculovirus programs with scale-up to 1,500-L for the first time in the industry for human use. To date, Fujifilm Diosynth has produced over 100 cell culture GMP batches, primarily using CHO cell and baculovirus technologies and manufactures onecell culture commercial product.
机译:业界领先的生物合同制造商Fujifilm Diosynth Biotechnologies位于NIC的Research Triangle Park(以前称为Diosynth Biotechnology)和英国Billingham(以前是Avecia Biologies)为生物制药行业提供第三方合同开发​​和制造服务。 Fujifilm Diosynth Biotechnologies已经提供了在细胞培养中生产的临床和商业重组蛋白已有14年以上的历史。我们在微生物开发和制造方面拥有丰富的经验,并且在细胞培养领域拥有同等的经验。我们的开发经验包括30多个细胞培养过程,其中三分之二是CHO衍生的,以及20多个单克隆抗体程序。此外,Fujifilm Diosynth已执行了四个杆状病毒程序,规模扩大到了1,500-L,这在业内是人类首次使用。迄今为止,Fujifilm Diosynth已主要使用CHO细胞和杆状病毒技术生产了100多个细胞培养GMP批次,并生产了单细胞培养商业产品。

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