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多元数据分析作为一种 PAT 工具在早期生物工艺开发数据中的应用。

Multivariate data analysis as a PAT tool for early bioprocess development data.

机构信息

Crucell Holland BV, Process Development Department, Archimedesweg 4-6, 2333 CN Leiden, The Netherlands.

出版信息

J Biotechnol. 2013 Sep 10;167(3):262-70. doi: 10.1016/j.jbiotec.2013.07.006. Epub 2013 Jul 18.

DOI:10.1016/j.jbiotec.2013.07.006
PMID:23871900
Abstract

Early development datasets are typically unstructured, incomplete and truncated, yet they are readily available and contain relevant process information which is not extracted using classical data analysis techniques. In this paper, we illustrate the power of multivariate data analysis (MVDA) as a Process Analytical Technology tool to analyze early development data of a PER.C6® cell cultivation process. MVDA increased our understanding of the process studied. Principal component analysis enabled a thorough exploration of the dataset, identifying causes for batch deviations and revealing sensitivity of the process to scale. These findings were previously undetected using traditional univariate analysis. The lack of structure and gaps in the early development datasets made it impossible to fit them to more advanced partial least square regression models. This paper clearly shows that MVDA should be routinely used to analyze early development data to reveal relevant information for later development and scale-up. The value of these early development runs can be greatly enhanced if the experiments are well-structured and accompanied with full process analytics. This up-front investment will result in shorter and more efficient process development paths, resulting in lower overall development costs for new biopharmaceutical products.

摘要

早期开发数据集通常是非结构化的、不完整的和截断的,但它们很容易获得,并且包含了使用经典数据分析技术无法提取的相关过程信息。在本文中,我们将说明多元数据分析 (MVDA) 作为一种过程分析技术工具的强大功能,用于分析 PER.C6®细胞培养过程的早期开发数据。MVDA 增加了我们对所研究过程的理解。主成分分析使我们能够彻底探索数据集,确定批次偏差的原因,并揭示过程对规模的敏感性。使用传统的单变量分析无法检测到这些发现。早期开发数据集缺乏结构和空白,使得它们无法拟合到更先进的偏最小二乘回归模型中。本文清楚地表明,MVDA 应常规用于分析早期开发数据,以揭示后期开发和放大的相关信息。如果实验设计良好并配备完整的过程分析,这些早期开发运行的价值将大大提高。这种前期投资将导致更短、更有效的工艺开发路径,从而降低新型生物制药产品的总体开发成本。

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