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Merck

Emprove® Chromatography

Selecting chromatography products and methods can be a challenge, as they are highly process-specific and often play a critical role at multiple steps from early to late downstream.  

To simplify this challenge for biopharmaceutical manufacturers, our Emprove® Chromatography portfolio is built to address specific needs for streamlined resin selection and qualification. 

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Emprove® Chromatography Resins Currently in Scope*

Product

Catalog Number

Material Qualification Dossier

Quality Management Dossier

Operational Excellence Dossier

Eshmuno® A1.20089
Eshmuno® CMX120650
Eshmuno® CPX1.20083
Eshmuno® CPFT1.20093TBD
Eshmuno® HCX1.20087
Eshmuno® Q1.20079
Eshmuno® S1.20078
Fractogel® EMD COO (M)1.16886
Fractogel® EMD DEAE (M)1.16883
Fractogel® EMD DMAE (M)1.16884
Fractogel® EMD SE Hicap (M)1.14894
Fractogel® EMD SO3 (M)1.16882
Fractogel® EMD SO3 (S)1.16890
Fractogel® EMD TMAE (M)1.16881
Fractogel® EMD TMAE (S)1.16887
Fractogel® EMD TMAE Hicap (M)1.10316
Fractogel® EMD TMAE Medcap (M)1.16885
Fractogel® EMD BioSEC (S)1.10317TBD
Fractogel® EMD Chelate (M)1.10338TBD
*Status as per Q4 2022, constantly updated

Dossiers that support resin qualification, risk assessment, and process optimization

As part of the Emprove® Program, resins in our Emprove® Chromatography portfolio include comprehensive dossiers that facilitate your qualification, risk assessment, and process optimization efforts.

Speeds up resin qualification and supports regulatory filing preparation. It includes content on manufacturing processes, product characterization, regulatory certificates, storage and shelf life information, and more.
  • General information
  • Manufacture
  • Quality information
  • Specification, release criteria
  • Packaging material
  • Regulatory statements (BSE/TSE, Allergens…)
  • Storage and shelf life
  • Environmental statement
Free of charge*
* The Material Qualification Dossier is free of charge and available on the specific product detail pages of our website after log-in. It can also be downloaded through the Emprove® Suite.
Supports quality risk assessment by offering extended information on quality management system, supply chain, supplier and process evaluation statement, as well as stability data.
  • Supply chain information
  • Product quality self-assessment
  • Supplier and process evaluation statement
  • Stability data
 
Supports process optimization efforts as well as extended and safety risk assessment. It contains extractables profiles aligned with current draft of USP<665>. It also includes information on elemental impurities, residual solvents, product quality reports and analytical procedures.
  • Manufacturing process (detailed information)
  • Elemental impurity information
  • Residual solvents statement
  • Extractables profile
  • Reference spectrum
  • Product quality report
  • Analytical procedure
 

The new Emprove<sup>®</sup> Suite

THE NEW EMPROVE® SUITE: SPEED THROUGH COMPLEXITY WITH CONFIDENCE

Compliance with current Good Manufacturing Practices is a continuum. Changes are inevitable. Audits and periodic reviews are necessary.

Take a seat: The Emprove® Suite is here to improve your risk assessment journey. This  Information-as-a-Service digital platform is your co-pilot to support your need for convenient access to reliable information – anywhere, anytime. A subscription helps you stay current:  You can  not only easily find, view and download Emprove® Dossiers, but also to “opt-in” to notification updates to be informed of changes to documents. You can also generate Emprove® Dossier download metrics and reports, and so much more.

Ultimately, a subscription to the Emprove® Suite empowers you to:

  • take advantage of everything the Emprove® Program has to offer
  • collaborate and share information globally
  • speed your way through the complexity of compliance with confidence




To subscribe today, simply complete and submit the reply form below after reading our Emprove® terms and conditions.

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