• Implementation of chemometrics, design of experiments, and neural network analysis for prior process knowledge assessment, failure modes and effect analysis, scale‐down model development, and process characterization for a chromatographic

    29 days ago - By Wiley

    Abstract
    Process understanding and characterization forms the foundation, ensuring consistent and robust biologics manufacturing process. Using appropriate modeling tools and machine learning approaches, the process data can be monitored in real time to avoid manufacturing risks. In this article, we have outlined an approach toward implementation of chemometrics and machine learning tools to model and predict the behavior of a mixed-mode chromatography step for a biosimilar as a case study. The process development data and process knowledge was assimilated into a prior process knowledge...
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