• Advancing Raman model calibration for perfusion bioprocesses using spiked harvest libraries

    3 days ago - By Wiley

    Abstract
    Background
    Raman spectroscopy has gained popularity to monitor multiple process indicators simultaneously in biopharmaceutical processes. However, robust and specific model calibration remains a challenge due to insufficient analyte variability to train the models and high cross-correlation of various media components and artifacts throughout the process.
    Main methods
    A systematic Raman calibration workflow for perfusion processes enabling highly specific and fast model calibration was developed. Harvest libraries consisting of frozen harvest samples from multiple CHO cell culture...
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  • Converting a mAb downstream process from batch to continuous using process modeling and process analytical technology

    3 days ago - By Wiley

    Abstract
    The biopharmaceutical market is driving the revolution from traditional batch processes to continuous manufacturing for higher productivity and lower costs. In this work, a batch mAb downstream process has been converted into an integrated continuous process with the combination of multiple techniques. For process intensification, two batch mode unit operations (protein A capture chromatography, ultrafiltration/diafiltration) are converted into continuous ones; For continuity, surge tanks were used between adjacent steps, and level signals were used to trigger process start or...
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