Biologics manufacturing have undergone a major transformation in the recent past to ensure the production of safe and quality products consistently. Moreover, the cost of failure is very high in this business, where a bad batch of drug material could not only lead to serious public health issues but also operational cost and time to ramp up. Therefore, batch-to-batch reproducibility have become a mandate for the biopharmaceutical industry and often encouraged by the regulatory authorities.
To keep close watch over the process and maintain strict control over manufacturing process, companies invest in building modern production plants equipped with systems for automated control as well as comprehensive data collection and archiving. This presentation discusses how online measurements are used to develop soft sensors to monitor key process variables online, which otherwise available offline using OSI PI. Also, how this soft sensor is used for process monitoring and fault detection. Thereby, enhancing the process robustness and efficiency of manufacturing process.