Classification and Diagnosis of Bioprocess Cell Growth Productions Using Early-Stage Data

Yuan JIN, S. Joe QIN*, Qiang HUANG, Victor SAUCEDO, Zheng LI, Angela MEIER, Siddhartha KUNDU, Bri LEHR, Salim CHARANIYA

*Corresponding author for this work

Research output: Journal PublicationsJournal Article (refereed)peer-review

7 Citations (Scopus)


Many industrial pharmaceutical manufacturing processes are composed of multiple-step batch operations. However, uncontrolled variations often occur during operations that affect the cell growth performance. Because of the complexity of biological processes, one leading challenge in process operation is the identification of potential causes of undesirable process variabilities. In this paper, we propose a classification and diagnosis strategy to analyze cell culture manufacturing variability in bioprocesses with the objective of unveiling hidden factors affecting process yield and performance. The proposed strategy includes two parts: (i) a clustering method performed in the principal component residuals that effectively separates the low lactate batches into different clusters and (ii) a fault diagnosis method based on regularized LDA contribution analysis for exploring the leading contributors to each of the low performance classes. The proposed strategy is applied to industrial production data collected over 8 years from a batch process. The effectiveness of the proposed approach is demonstrated on this data set, allowing the classification and diagnosis of the sources of the low performance situations.
Original languageEnglish
Pages (from-to)13469-13480
Number of pages12
JournalIndustrial and Engineering Chemistry Research
Issue number30
Early online date22 Jun 2019
Publication statusPublished - 31 Jul 2019
Externally publishedYes

Bibliographical note

This work is supported in part by Genentech, a member of the Roche Group.


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