Wright Chapman, Alves Christina, Kshirsagar Rashmi, Pieracci John, Estes Scott
Biogen, Technical Development, Cambridge, MA.
Codiak Biosciences, Upstream Process Development, Cambridge, MA.
Biotechnol Prog. 2017 Nov;33(6):1468-1475. doi: 10.1002/btpr.2548. Epub 2017 Sep 7.
The Biogen upstream platform is capable of delivering equivalent quality material throughout the cell line generation process. This allows us to rapidly deliver high-quality biopharmaceuticals to patients with unmet medical needs. The drive to reduce time-to-market led the cell engineering group to develop an expression system that can enable this strategy. We have developed a clonal Chinese Hamster Ovary (CHO) host cell line that can routinely produce consistent antibody material at high titers throughout the cell line generation process. This host line enables faster delivery of early phase material through use of the highly productive stable pool or a mixture of high performance clones. Due to unique characteristics of this cell line, the product quality of material from early cell populations is very comparable to material from the final clones. This lends itself to a "fast-to-tox" strategy whereby toxicology studies can be performed with representative material from an earlier cell population, thus accelerating the clinical timelines. Our new clonal host offers robust and consistent performance that enables a highly productive, flexible process and faster preclinical timelines. © 2017 American Institute of Chemical Engineers Biotechnol. Prog., 33:1468-1475, 2017.
百健的上游平台能够在整个细胞系生成过程中提供质量相当的材料。这使我们能够迅速将高质量生物制药产品提供给有未满足医疗需求的患者。缩短上市时间的需求促使细胞工程团队开发出一种能够实现这一战略的表达系统。我们已经开发出一种克隆中国仓鼠卵巢（CHO）宿主细胞系，该细胞系在整个细胞系生成过程中能够常规地以高滴度产生一致的抗体材料。这种宿主细胞系通过使用高产稳定细胞池或高性能克隆的混合物，能够更快地提供早期阶段的材料。由于该细胞系的独特特性，早期细胞群体产生的材料的产品质量与最终克隆产生的材料非常相似。这有助于采用“快速进入毒理学研究”策略，即可以用来自早期细胞群体的代表性材料进行毒理学研究，从而加快临床进程。我们的新克隆宿主具有强大且一致的性能，能够实现高产、灵活的工艺以及更快的临床前进程。© 2017美国化学工程师学会 生物技术进展，33:1468 - 1475，2017年。
