(141c) Data-Driven Real-Time Operation Support for Decontamination Processes in Biopharmaceutical Drug Product Manufacturing
- Conference: AIChE Annual Meeting
- Year: 2018
- Proceeding: 2018 AIChE Annual Meeting
- Group: Pharmaceutical Discovery, Development and Manufacturing Forum
- Time: Monday, October 29, 2018 - 1:20pm-1:45pm
Our suggested framework allows for probability-based performance evaluation and forecasting of processes in commercial operation. Application of the framework would enable operators to predict batch failures and to take pre-emptive action. The framework employs machine learning algorithms within a three-step procedure to classify the data based on batch quality, train a model to make predictions and finally a decision-making step based on the results of the previous two steps.
The first step of the procedure involves statistically defining quality boundaries using pre-recorded data, e.g., temperature, pressure, hydrogen peroxide content. Due to the high correlation of the recorded data, a principal component analysis is used to obtain a reduced set of independent variables (principal components). The results are used to define batch quality boundaries. The recorded data is then split into training and test data for a machine learning algorithm. Several algorithms such as k-nearest neighbors and random forest are compared to find the most suitable algorithm for the studied case data. The trained model should then predict process parameters for the remaining process duration based on the input from only a few seconds of measured operation parameters. The third step of the procedure provides a predictive monitoring tool which combines the previously defined operation boundaries with the predictions from the specified machine learning algorithm. The tool would allow for predicting failure probabilities along with the expected failure time. A reverse PCA is then performed to pinpoint critical process parameters. This allows operators to take precautionary preventive measures, e.g., adjustment of the pumps and valves or interruption of the process.