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  • Emprove® Chromatography | Merck

    Emprove® Dossiers for Purification in Biomanufacturing Process High performing resins meet regulatory excellence Any component and raw material used at a later stage of the biomanufacturing process is considered a risk, as it could add a bioburden to the final drug product. While being essential, chromatography steps are often a challenge as they are highly process specific and might be present from early to late downstream. Therefore, information is crucial for manufacturers when selecting chromatography methods and products.

  • Emprove® Dossiers for Chemicals | Merck

    Emprove® Dossiers for Chemicals: Satisfy Your Regulatory Requirements. Three Levels of Information Supporting Quality Risk Assessment and Regulatory Requirements To address evolving regulatory requirements, we are constantly developing our Emprove® Dossier library to better meet your regulatory challenges. The information on each of our Emprove® Evolve, Emprove® Essential and Emprove® Expert products facilitates your raw material qualification, risk assessment and process optimization efforts.

  • Emprove® CCM | Merck

    Ease your regulatory efforts with Emprove® dossiers for Cell Culture Media for Upstream Processes. Cell culture media (CCM) have a critical role in manufacturing as they drive the productivity of upstream processes and help ensure critical quality attributes of the final drug product. Therefore it is recommended that media be included in drug product risk assessments.