Process Analytical Technology (PAT): Build Quality into Biopharmaceutical Processes
In-line Raman monitoring and on-line automated aseptic sampling speed analysis through real-time measurement and analytical integration
The application of PAT requires analytical monitoring, data analysis, process control, and continuous optimization to be successful. Process monitoring leverages technologies such as sensors and sampling, and analytical methods such as spectroscopy. Automated aseptic sampling integrates process streams with analytical systems to accelerate quality testing and data access. Raman spectroscopy provides in-line, non-invasive molecular insight into critical process parameters (CPPs) such as glucose and lactate, and critical quality attributes (CQAs) such as protein titer and glycosylation. Together, these technologies support monitoring, modeling, and automation—allowing manufacturers to better understand, control, and optimize processes while improving product consistency, efficiency, and overall process robustness under GMP conditions.
Direct Monitoring of Upstream Bioprocesses Using Raman Ready-To-Use Embedded Models and Transfer Learning Algorithm
Read how ready-to-use Raman models simplify calibration and allow real-time monitoring of CPPs and CQAs in upstream processes quickly. See results from upstream and downstream runs and how a transfer learning algorithm can fine-tune model accuracy after a single batch.
DOWNLOAD THE APP NOTEAccelerate Process Development with Automated Aseptic Sampling
Automated aseptic sampling is an innovative technology that enhances bioprocesses by reducing contamination risks and increasing measurement frequency. Streamlining sampling procedures, it allows improved efficiency and process understanding via near real-time monitoring.
DOWNLOAD THE APP NOTEReady-to-Use Raman for Upstream Monitoring — Expanding Insights into Downstream & Novel Modalities
This webinar presents findings from fed-batch and perfusion cell culture runs utilizing ready-to-use models for in-line, real-time measurement of glucose, lactate and mAb titer. The capabilities of on-line Raman sensor for critical attributes monitoring in downstream & new modalities areas are also presented.
WATCH ON DEMANDIntegration of Automated Sampling with LC-MS as a PAT Tool for USP Glycosylation Monitoring and Control
This webinar explores how automation strategies and control schemes facilitate rapid analytical results, crucial for managing glycosylation variability that affects product quality. The MAST® Autosampling Solution and Agilent 2D-LC/TOF MS was used to enable glycosylation monitoring during perfusion cell culture.
WATCH ON DEMANDEnabling accelerated Raman model calibration for seamless and reproducible real-time monitoring by combining Raman and automated sampling technologies
In this case study, a workflow aimed at expediting the integration of an in-line Raman analyzer for a bioreactor application is assessed. This is achieved by leveraging an on-line technology for automated sampling and data analysis. It accelerates the Raman model building phase, facilitating in-line, real-time monitoring of CPPs and CQAs during the manufacturing process.
READ THE APP NOTEAutomated Aseptic Sampling for Accelerated Access to Process and Quality Data in Upstream Bioprocessing
Automated sampling offers the ability to automate process analytics with online data acquisition. With an automated sampling system, samples can be pulled from the process stream and sent to different analyzers to obtain data without operator intervention. This can replace both at-line and off-line sample analysis because a variety of analyzers can be connected to the sampling system.
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