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使用不同强化N - 1种子策略的mAb生产的Feed-batch性能配置文件是CHO细胞系依赖的

Yawen Tang¹, Jianlin Xu¹, Mengmeng Xu¹

¹Global Product Development and Supply, Bristol Myers Squibb Company, Devens, Massachusetts, USA.

Biotechnology progress

|February 28, 2024

概括

为单克隆抗体产生N-1种子阶段的优化会影响细胞生长和生产力. 富化批量和 perfusion N-1 策略之间的选择取决于细胞系,影响最终的生产结果.

科学领域:

生物技术是生物技术.
生物工艺工程生物工艺工程
细胞培养技术细胞培养技术

背景情况:

优化细胞培养过程侧重于N-1种子阶段,以实现N阶段生物反应器的更高的注射密度.
N-1阶段的工艺强化可以通过非 perfusion (丰富批量/养批量) 或 perfusion 方法实现.
较高的N-1可活细胞密度 (VCD) 旨在缩短生产时间并提高体积生产率.

研究的目的:

评估不同N-1强化策略 (缩批量与 perfusion) 对N阶段养批量生物反应器中细胞生长和单克隆抗体 (mAb) 生产力的影响.
确定N-1工艺选择是否会影响下游的mAb生产结果.
评估N-1强化策略对mAb生产的细胞系依赖性.

主要方法:

培养了三个代表的中国仓鼠卵巢 (CHO) 细胞系,产生不同的mAbs.
使用了丰富批次 (EB) 和 perfusion N-1 种子培养方法.
在所有条件下,以供应批量模式运行N阶段生产生物反应器.

主要成果:

在EB和 perfusion N-1种子之间,N阶段细胞生长和mAb生产率在三种CHO细胞系中的两种是可比的.
在第三个细胞系中观察到N阶段细胞生长和mAb生产力的显著差异.
细胞特异性生产率的变化甚至在具有相似整体生长特征的细胞系中也被发现.

结论:

N-1种子强化策略对mAb生产的影响取决于细胞系.
选择N-1强化方法和由此产生的种子状态可以影响N阶段生产的结果.
选择N-1强化策略是mAb制造上游优化的一个关键因素.

关键词:

中国仓鼠的卵巢细胞.丰富-批量 N − 1 个给养的批量这是一种单克隆抗体.perfusion N − 1 perfusion N − 1 perfusion N − 1 perfusion N − 1 perfusion N − 1 perfusion N − 1 perfusion N − 1 perfusion N − 1 perfusion N − 1 perfusion N − 1 perfusion N − 1 perfusion N − 1 perfusion N − 1 perfusion N − 1 perfusion N − 1 perfusion N − 1 perfusion N − 1 perfusion N − 1 perfusion N − 1 perfusion N − 1 perfusion N − 1 perfusion N − 1 perfusion N − 1 perfusion N − 1 perfusion N − 1 perfusion N − 1 perfusion 输入输入输入输入输入输入输入输入输入输入过程强化,过程强化.

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