Predictive Insights for Consistent Process Performance
In-process monitoring during biomanufacturing is crucial for maintaining control over various parameters and ensuring the quality, efficiency, and reproducibility of the production process. By continuously tracking key variables such as cell viability, productivity, and critical process parameters, manufacturers can detect deviations in real-time and implement timely adjustments. This proactive approach not only minimizes the risk of product variations and batch failures but also enhances the overall robustness of biomanufacturing processes, contributing to the production of high-quality and consistent biopharmaceutical products.
Analytical challenges in in-process monitoring during biomanufacturing primarily revolve around the dynamic nature of the production environment as well as the complex nature of the components of advanced therapies such as viruses and mammalian cells. Cellular heterogeneity, varying conditions, and the need for real-time insights pose hurdles in capturing accurate and representative data. Additionally, integrating diverse analytical techniques and ensuring compatibility across different scales of production can be challenging. Overcoming these challenges requires advanced analytical tools that provide real-time, multiparametric data, allowing for a comprehensive understanding of the bioprocess and facilitating informed decision-making during production.
Laser Force Cytology™ (LFC) revolutionizes in-process monitoring during biomanufacturing by offering real-time, label-free analysis of individual cells. Its single-cell resolution provides a detailed understanding of cellular heterogeneity, allowing for nuanced insights into the dynamic changes occurring during the production process. LFC’s ability to capture multiparametric data in real time empowers biomanufacturers to precisely monitor and adjust critical parameters, ensuring optimal conditions, and enhancing the overall control and efficiency of the bioproduction process.
Process Monitoring Using Laser Force Cytology™
Radiance® provides real-time data for cell health conditions, characterizing changes and ensuring consistent process performance.
Contamination can be detected quickly, allowing for improved process and quality controls.
Cellular changes as a result of bacterial contamination are distinct from other events such as transfection and transduction.
Rapid Detection of Out-of-Spec (OOS) Batches
In Process Manufacturing Application
Radiance® data can be used to monitor production runs in real time to understand the expected process behavior.
Batches that deviate from normal operating conditions can be quickly identified in order to provide corrective action as required, saving time and resources.
