种子扩增强化

The purpose of a seed train is the generation of an adequate number of cells for the inoculation of a production bioreactor. The cells are usually run through many cultivation systems which become larger with each passage (e.g. T-flasks, roller bottles or shake flasks, small scale bioreactor systems and subsequently larger bioreactors). The production bioreactor (N stage) is inoculated out of the largest seed train scale. 

传统种子扩增 

挑战

• 3-4周内到达生产生物反应器
• 步骤繁多，有些步骤需要开放式操作
• Seed variability creates scheduling risk and/or output variability

强化的种子扩增

Intensified seed trains perform process intensification, using a cell retention device such as the XCell ATF^® Device, at optimal points during cell expansion to attain the highest cell density inoculum for the production (N) bioreactor. Seed train intensification promotes flexibility and scalability, allowing small labs and global players alike to grow the exact amount of cell culture required, irrespective of whether they are needed for a clinical study, a new therapy or a personalized treatment.

福利

• 缩短生产生物反应器中的运行时间
• 每年更多批次
• 更短的种子扩增时间
• 降低工厂占地
• 提高灵活性
• 降低产品成本

Repligen solutions help overcome key challenges in seed train intensification, with hands-on process and implementation consultation from global Field Applications Specialists.

咨询专家

选项1 | N-1 强化

在生产生物反应器(N)之前的步骤(N-1)中强化细胞生长。该工艺强化通过在N-1生物反应器上配置细胞截留装置、获得高细胞密度和活性而实现。这样，可使用更高的起始细胞密度接种生产生物反应器，缩短生产生物反应器运行时间。从而显著提高工厂的产量，而不需要直接改变核心生产工艺。

根据现有设施布局，可对该工艺强化方式进行调整，常见的一种方式是一个N-1生物反应器可以接种两个生产罐。 

Click on the workflow link below to find productivity and throughput solutions you can implement today.  

More on N-1 Perfusion

选项2 | N-2或更早的强化

Perform process intensification earlier in the workflow by attaching the XCell ATF^® Device to the N-2 or earlier bioreactors. This can save as much as 1 week in the seed train and reduce or eliminate several bioreactors later in the workflow. This means less bioreactors to purchase, operate, clean, and validate - saving clean room floor space while mitigating risk.

Click on the workflow link below to find productivity and throughput solutions you can implement today. 

选项3 | 大体积高密度（LVHD）冻存工艺中间体

通过生产并冻存中间体细胞，从而将生产与细胞库以及多变的早期细胞培养扩增分开。这确保了每次提供给生产的细胞具有高细胞密度和活性以及已知的体积。该工艺强化选项可以在中央工厂中执行，并分布至全球，使“按需”安排接种变得容易得多。

Click on the workflow link below to find productivity and throughput solutions you can implement today. 

选项4 | 冻存工艺中间体及N-1强化

结合冻存工艺中间体和N-1或更早的强化。这使得按需生产成为可能，并为批量或连续操作提供了一个真正灵活的设施。

• 显著降低的占地和更少的设备
• 降低用于设备和洁净室的资本支出（CAPEX）
• 更少的操作步骤
• 更多可重复的输出
• 设备更快的轮转，每年运行更多的批次

Click on the workflow link below to find productivity and throughput solutions you can implement today.