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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 Filtration and Single-use | Merck

    Optimized information to fast-track your drug to market. Emprove® Dossiers for Filters are grouped according to product families with the same materials of construction, production processes, and packaging components. Emprove® Dossiers for Single-Use Components are available beginning with the most commonly used components in the process. Assembly level information can be developed from the individual dossiers available for components forming the part of the single use assemblies.

  • Phase III | Emerging Biotech | Merck

    Phase III trials use a much larger patient population - in the thousands - to give statistical weight to results that can prove safety and efficacy.

  • Emprove® Extractables Data for Filters and Single-use Systems | Merck

    Enabling a More Robust Extractables and Leachables Risk Assessment extractables and potential leachables. All polymeric components such as the filters and single-use systems used in biopharmaceutical manufacturing must be assessed for safety through an evaluation of extractables and potential leachables. Extractables are compounds that can be extracted from these materials while leachables are compounds that leach from the materials into the process stream.

  • GMP and HACCP

    As a manufacturer of pharmaceutical active substances and excipients, food additives and other food ingredients as well as active cosmetic substances, Merck operates according to recognized international quality standards and relevant regulations.

  • Emprove Program | Merck

    Your fast track through regulatory challenges With the industry facing ever increasing regulations for risk assessment, we've broadened the scope of our Emprove® portfolio and dossier structure to help you meet the latest regulatory requirements and speed your way through the regulatory maze.