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GEN Webinars: January 01, 1990

Innovative Analytical Strategies for Monitoring Critical Process Parameters and Critical Quality Attributes (CQA)

<p> Biopharmaceuticals are complex molecules produced by living cells, with strict control of bioprocessing being required to ensure the production of high-quality therapeutic proteins. Deviations in process parameters such as pH, temperature, or dissolved oxygen can cause perturbations in cellular processing, and may lead to cellular expression of therapeutic proteins with altered product quality attributes.</p> <p> A key desire by biopharmaceutical manufacturers is process analytical technology (PAT) for process monitoring and rapid analytical information generation. While techniques such as infrared and Raman spectroscopy have been widely implemented for small API manufacture, the complexity of bioprocessing and therapeutic proteins requires more informative technologies.</p> <p> Mass spectrometry (MS) coupled to liquid-phase separations offers immense potential for implementation as an online characterization tool, providing a wealth of multi-attribute information at all stages throughout the bioprocess with greater confidence and depth of product attribute knowledge, improving safety and potency.</p> <p> Here, we will present an overview of the current state of bioprocessing monitoring, discuss areas for improvement and implementation of PAT, and describe the potential of GMP-compliant MS characterization throughout bioprocess and lot release.</p> <h3> Who Should Attend</h3> <ul> <li> Process development scientists</li> <li> Biopharmaceutical development scientists</li> <li> Biopharmaceutical lab managers</li> <li> Those interested in technology adoption and lab efficiency programs</li> <li> QA/QC analysts</li> <li> Translational research scientists</li> </ul> <h3> You Will Learn</h3> <ul> <li> Current industry trends and challenges of bioprocessing production and monitoring</li> <li> What we need to monitor, how it’s currently performed and future strategies</li> <li> Key principles of the multi-attribute method (MAM) and advantages of MS for lot release</li> <li> The need for GMP-compliant high-resolution CQA quantitation as part of a MAM workflow</li> <li> The detection of host cell proteins at low PPM levels, CQA changes under stress (even at ultra-low stoichiometry), and new feature detection for purity analysis</li> </ul>