Real-Time Monitoring: Why Have It And How To Get It

Biopharma production processes are inherently challenging due to the heterogeneity of biological products, which arises from the presence of cellular entities that are highly sensitive to variations in the culture medium. Implementing real-time monitoring can help ensure product quality, safety, and compliance. Real-time monitoring probes enable the continuous observation of cell states, nutrient levels, by-product concentrations, and product formation. These tools can trigger corrective actions when variables deviate from their normal operating ranges or setpoints, thus preventing product quality issues, product loss, batch reprocessing, and batch rejection.

Real-time monitoring optimizes processes, enhances efficiency, and reduces costs, which is particularly vital in the field of cell and gene therapy where the cost-effective, large-scale production of viral vectors or cells is required. Additionally, real-time monitoring can be applied downstream to ensure impurity removal and maintain product quality standards.

Automation and real-time monitoring across all process steps facilitate continuous manufacturing. Continuous manufacturing can reduce plant footprint as well as capital and labor costs while offering greater scalability, efficiency, and flexibility compared to traditional batch processing. Real-time monitoring tools provide the rapid response and control needed for successful continuous manufacturing.

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