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  • A development and scale up strategy in downstream processing using concomitant impurity monitoring

    A development and scale up strategy in downstream processing using concomitant impurity monitoring A_development_and_scale_up_strategy_in_downstream_processing_using_concomitant_impurity_monitoring

     

     

    Prof.-Christoph-Herwig spletna-stran

    Presented by: Uni. Prof. Dr. Christoph Herwig
    Vienna University of Technology

    The development and control of biopharmaceutical processes is still a time extensive and complex task. This is mainly due to the fact that the developers face complexity originating on the one hand from the product quality attributes, such as glycosylation and host cell impurities, and on the other hand from the process and the biological catalyst, such as pH, feed rates, reaction kinetics and side products.
    Following Quality by Design principles, a robust process is obtained if the link between the Critical Quality Attributes (CQA) and the Critical Process Parameters (CPP) is known (design space) and can be controlled (control space). As of today, however, the measurement of the CQAs is hardly available in a timely controlled way, so that for control purposes mainly CPPs are used.
    This contribution proposes a novel approach using direct measurements of CQAs. We propose a CQA analyzer, which is based on a HPLC principle combined monolithic columns, which is used horizontally along the entire process, from upstream to downstream processing. Together with advanced multivariate data analysis algorithms, the chromatogram can be used as a fingerprinting method, allowing to track host cell impurities CQAs in a timely controlled way. Hence we present a PAT tool as per original definition.

    A development and scale up strategy in downstream processing using concomitant impurity monitoring from BIA Separations on Vimeo.

  • Meeting the Challenges of Applying PAT to Biopharmaceutical Manufacturing

    Meeting the Challenges of Applying PAT to Biopharmaceutical Manufacturing Meeting_the_Challenges_of_Applying_PAT_to_Biopharmaceutical_Manufacturing

    BPTC Susan Dana Jones 66406 headshot

     

     

     

    Presented by: Susan Dana Jones, PhD
    BioProcess Technology Consultants, Inc.

    While Process Analytical Technology (PAT) has been used for decades to ensure process reproducibility, applying PAT to biopharmaceutical manufacturing is much more complex due to the complexity of biomolecules and the batch to batch variability resulting from slight environmental changes during production. Standard analytical methods for monitoring cell culture conditions, such as NIR, pH, or DO2 do not measure product concentration or quality. As HPLC methods can generally be developed to provide this information, a reliable, informative on-line HPLC method would be a very useful PAT method for biomolecules. In this webinar, examples of PAT in biopharmaceutical manufacturing that takes advantage of the unique properties of specially designed CIM monolithic HPLC columns to provide rapid, actionable information will be presented. These will demonstrate the utility of this robust PAT to speed up development and optimization of both the upstream and downstream processes. These methods can later serve as accurate methods that provide actionable data during manufacturing.

    Meeting the Challenges of Applying PAT to Biopharmaceutical Manufacturing

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