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A distribution-based approach for determining lot sizes in the filling of human-induced pluripotent stem cells

机译：基于分布的方法来确定人类诱导的多能干细胞的填充量

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Introduction Toward the commercial production of human-induced pluripotent stem (hiPS) cells, the process design and operation have to be standardized. Considering the change in cell quality during filling of the hiPS cells into containers, lot sizing during filling also needs to be standardized. Methods We present a distribution-based approach that can be used for determining the lot sizes in the filling of hiPS cells by considering change in cell quality during filling. The approach describes the “survival capability” of the cells as a continuous probability distribution, and expresses the change in quality during filling by “trimming” the distribution. Results A lognormal distribution was assumed as the survival capability distribution of the cells that were to be filled. The distributions after different filling times were calculated, which were compared with the distribution of the initial filling time regarding the yield of the cells and the similarity. These conditions served as strong quality constraints in determining an economically optimal lot size. Conclusions The presented conceptual approach would be effective in determining the lot size considering the change in cell quality during filling. For actual application, measuring the distribution information on the survival capability of hiPS cells is encouraged.
机译：引言为了商业化生产人类诱导的多能干（hiPS）细胞，必须对过程设计和操作进行标准化。考虑到在将hiPS细胞填充到容器的过程中细胞质量的变化，填充期间的批量大小也需要进行标准化。方法我们提出了一种基于分布的方法，该方法可通过考虑填充过程中细胞质量的变化来确定hiPS细胞填充的批量大小。该方法将细胞的“生存能力”描述为连续的概率分布，并通过“修剪”分布来表示填充过程中质量的变化。结果假定对数正态分布为要填充的细胞的存活能力分布。计算了不同填充时间后的分布，将其与关于细胞产量和相似性的初始填充时间的分布进行比较。这些条件在确定经济上最佳的批量时成为强烈的质量约束。结论考虑到灌装过程中细胞质量的变化，提出的概念性方法在确定批量时将是有效的。对于实际应用，鼓励测量有关hiPS细胞存活能力的分布信息。

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