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® A	1.20089	✓	✓	✓
Eshmuno® CMX	120650	✓	✓	✓
Eshmuno® CPX	1.20083	✓	✓	✓
Eshmuno® CPFT	1.20093	✓	✓	TBD
Eshmuno® HCX	1.20087	✓	✓	✓
Eshmuno® Q	1.20079	✓	✓	✓
Eshmuno® S	1.20078	✓	✓	✓
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)	1.10317	✓	✓	TBD
Fractogel® EMD Chelate (M)	1.10338	✓	✓	TBD
*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.

Material Qualification Dossier

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.

Quality Management Dossier

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

Operational Excellence Dossier

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^® 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

Related Product Resources

Brochure: High performing resins meet regulatory excellence
Brochure: Sample Emprove^® Chromatography Dossier – Quality Management
White Paper: A practical approach for determining extractables in chromatography resins in the light of the upcoming USP chapter
Webinar: Extractables profiles for chromatography resins – adapted approach of upcoming USP <665>

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Emprove^® Learning

Each product portfolio is supported with Emprove® Dossiers which provide comprehensive, up-to-date documentation to help you navigate regulatory challenges, manage risks, and improve your manufacturing processes.

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