Emprove® Chromatography
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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.
Emprove® Chromatography Resins Currently in Scope* | ||||
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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.
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| Free of charge*
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* 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.
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| 2.000 €
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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.
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| 7.400 €
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Emprove® Suite: 24/7 online access to all our dossiers
Unlock all the benefits of the Emprove® Program by subscribing to our Emprove® Suite. Available exclusively for subscribers, all dossiers of the entire Emprove® portfolio can be accessed at your convenience.
- Subscriptions of one, two, or five years
- 24/7 online access
- Constantly updated
- Optimized searches
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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