Leveraging In Silico Data for the Development and Implementation of Multivariate Statistical Process Monitoring Models in Monoclonal Antibody Manufacturing

The design and development of a robust and consistent manufacturing process for monoclonal antibodies (mAbs), augmented by advanced process analytics capabilities, is a key current focus area in the pharmaceutical industry. In this work, we describe the development and operationalization of multivariate statistical process monitoring (MSPM), a data-driven modelling approach, to monitor biopharmaceutical manufacturing processes. This approach helps in understanding the correlations between the various variables and is used for the detection of the deviations and anomalies that may indicate abnormalities or changes in the process compared to the historical dataspace. Therefore, MSPM enables early fault detection with a scope for preventative intervention and corrective actions. In this work, we will additionally cover the value of in silico data in the development of MSPM models, principal component analysis (PCA), and batch modelling methods, as well as refining and validating the models in real time.