Suigyama Hirokazu, Shiokaramatsu Masaki, Kino-Oka Masahiro
Department of Chemical System Engineering, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8656, Japan.
Department of Biotechnology, Osaka University, 2-1 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Regen Ther. 2019 May 17;12:94-101. doi: 10.1016/j.reth.2019.04.012. eCollection 2019 Dec 15.
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.
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.
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.
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.
为实现人诱导多能干细胞（hiPS细胞）的商业化生产，必须对工艺设计和操作进行标准化。考虑到将hiPS细胞填充到容器过程中细胞质量的变化，填充过程中的批量大小也需要标准化。
我们提出了一种基于分布的方法，通过考虑填充过程中细胞质量的变化，可用于确定hiPS细胞填充时的批量大小。该方法将细胞的“存活能力”描述为连续概率分布，并通过“修剪”分布来表示填充过程中的质量变化。
假设对数正态分布为待填充细胞的存活能力分布。计算了不同填充时间后的分布，并将其与初始填充时间的分布在细胞产量和相似性方面进行比较。这些条件在确定经济上最优的批量大小时构成了严格的质量约束。
所提出的概念方法在考虑填充过程中细胞质量变化来确定批量大小方面将是有效的。对于实际应用，鼓励测量hiPS细胞存活能力的分布信息。
