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Merck Expands EmproveĀ® Portfolio with Chromatography Resins

Friday, May 29, 2020

Merck has expanded its Emprove® Portfolio with its Fractogel®, Eshmuno® and ProSep® chromatography resins, providing comprehensive product information to facilitate and accelerate selection, qualification, risk assessment and support regulatory filings. These chromatography resins join more than 400 raw and stating materials, filters and single-use components that are part of the Emprove® Program.

Chromatography is essential to ensuring purity and delivering the necessary yield of molecules throughout the biomanufacturing process and is highly process-specific. Selecting the most appropriate resin is essential to developing a robust and optimized purification process. The extensive content in the dossiers supporting these resins, now available through Merck’s Emprove® Program, eliminates the time-consuming process normally required to compile such information and helps streamline development and regulatory filings.  

The information provided in the dossiers for the chromatography resins reflect the latest regulatory requirements and anticipates industry expectations not yet covered by regulation. Three dossiers are available for each resin:

  •     The Emprove® Material Qualification Dossier accelerates resin qualification and supports regulatory filing preparation. It includes content on the manufacturing process, product characterization, regulatory certificates, storage and shelf life information, and more.
  •     The Emprove® Quality Management Dossier supports quality risk assessment by offering extended information on the quality management system, supply chain, supplier and process evaluation, as well as offering stability data.
  •     The Emprove® Operational Excellence Dossier supports process optimization efforts as well as extended and safety risk assessment. It contains extractables profiles aligned with the draft of USP <665>. It also includes information on elemental impurities, residual solvents, a product quality report and analytical procedures.

For more information about the Emprove® Program, visit merckmillipore.com/emprove.

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