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Screening and assessment of performance and molecule quality attributes of industrial cell lines across different fed-batch systems

机译：不同联邦批量系统产业细胞系性能和分子质量属性的筛选与评估

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The major challenge in the selection process of recombinant cell lines for the production of biologics is the choice, early in development, of a clonal cell line presenting a high productivity and optimal cell growth. Most importantly, the selected candidate needs to generate a product quality profile which is adequate with respect to safety and efficacy and which is preserved across cell culture scales. We developed a high-throughput screening and selection strategy of recombinant cell lines, based on their productivity in shaking 96-deepwell plates operated in fed-batch mode, which enables the identification of cell lines maintaining their high productivity at larger scales. Twelve recombinant cell lines expressing the same antibody with different productivities were selected out of 470 clonal cell lines in 96-deepwell plate fed-batch culture. They were tested under the same conditions in 50 mL vented shake tubes, microscale and lab-scale bioreactors in order to confirm the maintenance of their performance at larger scales. The use of a feeding protocol and culture conditions which are essentially the same across the different scales was essential to maintain productivity and product quality profiles across scales. Compared to currently used approaches, this strategy has the advantage of speeding up the selection process and increases the number of screened clones for getting high-producing recombinant cell lines at manufacturing scale with the desired performance and quality. (c) 2015 American Institute of Chemical Engineers Biotechnol. Prog., 32:160-170, 2016
机译：用于生物学的重组细胞系的选择过程中的主要挑战是呈现高生产率和最佳细胞生长的克隆细胞系的选择。最重要的是，所选择的候选者需要产生适当关于安全性和功效的产品质量轮廓，并且在细胞培养尺度上保留。我们开发了重组细胞系的高通量筛选和选择策略，基于它们在送入批次模式下操作的振动96-堤岸板的生产率，这使得能够在更大的尺度上保持其高生产率的细胞系。在96-·堤坝FED分批培养中选择了表达不同生产具有不同产品的相同抗体的12个重组细胞系。它们在50 mL排气抖动管，微观和实验室级生物反应器中的相同条件下进行测试，以便在更大的尺度上确认它们的性能。使用基本上相同的饲养方案和培养条件在不同尺度上是必不可少的，以维持横跨尺度的生产率和产品质量谱是必不可少的。与目前使用的方法相比，该策略具有加速选择过程的优点，并增加筛选克隆的数量，以便在制造规模中具有所需的性能和质量来获得高产生高产生的重组细胞系。 （c）2015美国化学工程研究所生物科技。 Prog。，32：160-170，2016

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