Methods for Estimating the Probability of Clonality in Cell Line Development.,Biotechnology Journal

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Methods for Estimating the Probability of Clonality in Cell Line Development.
Biotechnology Journal ( IF 3.2 ) Pub Date : 2019-12-16 , DOI: 10.1002/biot.201900289
Chun Chen ₁ , Kim Le ₁ , Huong Le ₁ , Kristi Daris ₁ , Neil Soice ₁ , Jennitte Stevens ₁ , Chetan T Goudar ₁

Affiliation

Mammalian cell banks for biopharmaceutical production are usually derived from a single progenitor cell. Different methods to estimate the probability that the cell banks are clonally derived, or the probability of clonality (PoC), associated with various cloning workflows have been reported previously. In this review, a systematic analysis and comparison of the methods used to calculate the PoC are provided. As the single cell deposition and high-resolution imaging technologies continue to advance and the cloning workflow evolves, an aligned understanding and best practice on estimating the PoC is necessary to compare different cloning workflows adopted across the biopharmaceutical industry and it will help to accelerate regulatory acceptance.

中文翻译：

估计细胞系发育中克隆概率的方法。

用于生物制药的哺乳动物细胞库通常来自单个祖细胞。先前已经报道了不同的方法来估计与各种克隆工作流程相关联的克隆克隆的细胞库的概率，或克隆性（PoC）的概率。在这篇综述中，提供了用于计算PoC的方法的系统分析和比较。随着单细胞沉积和高分辨率成像技术的不断发展以及克隆工作流程的发展，需要有一致的理解和最佳实践来估算PoC，以比较整个生物制药行业采用的不同克隆工作流程，这将有助于加快监管接受度。

更新日期：2020-01-07

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