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首页> 外文期刊>Biotechnology Progress >Case Study: An Accelerated 8-Day Monoclonal Antibody Production Process Based on High Seeding Densities
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Case Study: An Accelerated 8-Day Monoclonal Antibody Production Process Based on High Seeding Densities

机译：案例研究：基于高接种密度的加速8天单克隆抗体生产工艺

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This study describes the development work to shorten the monoclonal antibody (mAb) production time in CHO cell cultures from 14 days to 8 days without impacting mAb titer or product quality. The proposed process increases cell inoculation densities up to 25 X higher than a typical seeding density in the final production bioreactor, with the implementation of an ATF perfusion system in the N - 1 stage. Similar antibody titer and N-glycosylation profiles were reached in 8 days using the 25 x seed condition, as in 14 days using the 1 x seed condition. Acidic variants in the 25 x seed condition were 12-20% lower than the 1 x seed condition. These results indicate that an accelerated 8-day antibody production process utilizing a 25 x seeding strategy has the potential of achieving similar product quality and titer as the 1x seeding condition in a 14-day production process.
机译：这项研究描述了将CHO细胞培养物中单克隆抗体（mAb）的生产时间从14天缩短到8天而不影响mAb滴度或产品质量的开发工作。通过在N-1阶段实施ATF灌注系统，拟议的方法将细胞接种密度提高到比最终生产生物反应器中的典型接种密度高25倍。在使用25x种子条件下的8天中达到了相似的抗体效价和N-糖基化曲线，在使用1x种子条件下的14天中达到了相似的抗体效价和N-糖基化曲线。 25倍种子条件下的酸性变体比1倍种子条件下低12-20％。这些结果表明，采用25倍接种策略的8天加速抗体生产工艺具有在14天生产过程中达到与1倍接种条件相似的产品质量和效价的潜力。

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