Lookup NU author(s): Professor Jarka Glassey
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
Multivariate data analysis (MVDA) is a highly valuable and significantly underutilised resource in biomanufacturing. It offers the opportunity to enhance our understanding and leverage useful information from complex high-dimensional data sets, recorded throughout all stages of therapeutic drug manufacture. To help standardise the application and promote this resource within the biopharmaceutical industry, this paper outlines a novel MVDA methodology describing the necessary steps for efficient and effective data analysis. The MVDA methodology was followed to solve two case studies: a ‘small data’ and a ‘big data’ challenge. In the ‘small data’ example, a large-scale data set was compared to data from a scale-down model. This methodology enabled a new quantitative metric for equivalence to be established by combining a Two One-Sided Test (TOST) with principal component analysis. In the ‘big data’ example, this methodology enabled accurate predictions of critical missing data essential to a cloning study performed in the ambr15 TM system. These predictions were generated by exploiting the underlying relationship between the off-line missing values and the on-line measurements through the generation of a partial least squares model. In summary, the proposed MVDA methodology highlights the importance of data pre-processing, restructuring and visualisation during data analytics to solve complex biopharmaceutical challenges.
Author(s): Goldrick S, Sandner V, Cheeks M, Turner R, Farid SS, McCreath G, Glassey J
Publication type: Article
Publication status: Published
Journal: Biotechnology Journal
Issue: ePub ahead of Print
Online publication date: 16/10/2019
Acceptance date: 06/09/2019
Date deposited: 16/09/2019
ISSN (print): 1860-6768
ISSN (electronic): 1860-7314
Publisher: Wiley -VCH Verlag GmbH & Co. KGaA
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