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Emprove® Dossiers for Purification in Biomanufacturing Process
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.
Our new category Emprove® Chromatography addresses the specific needs when selecting and qualifying our chromatography resins.
Emprove® Dossiers Content
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
Free of charge*
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
- Stability data
Premium*
** Status May 2020
Emprove® Suite Subscription
Unlock Full Access to all dossiers today with the Emprove® Suite Subscription.
SubscribeProducts in scope
| Product | Catalog Number | Material Qualification Dossier | Quality Management Dossier | Operational Excellence Dossier |
|---|---|---|---|---|
| Eshmuno® A | 120089 | ✓ | ✓ | ✓ |
| Eshmuno® CMX | 120650 | ✓ | ✓ | ✓ |
| Eshmuno® CPX | 120083 | ✓ | ✓ | ✓ |
| Eshmuno® CP-FT | 120093 | ✓ | ✓ | TBD |
| Eshmuno® HCX | 120087 | ✓ | ✓ | ✓ |
| Eshmuno® Q | 120079 | ✓ | ✓ | ✓ |
| Eshmuno® S | 120078 | ✓ | ✓ | ✓ |
| Fractogel® EMD COO (M) | 116886 | ✓ | ✓ | ✓ |
| Fractogel® EMD DEAE (M) | 116883 | ✓ | ✓ | ✓ |
| Fractogel® EMD DMAE (M) | 116884 | ✓ | ✓ | ✓ |
| Fractogel® EMD SE Hicap (M) | 114894 | ✓ | ✓ | ✓ |
| Fractogel® EMD SO3 (M) | 116882 | ✓ | ✓ | ✓ |
| Fractogel® EMD SO3 (S) | 116890 | ✓ | ✓ | ✓ |
| Fractogel® EMD TMAE (M) | 116881 | ✓ | ✓ | ✓ |
| Fractogel® EMD TMAE (S) | 116887 | ✓ | ✓ | ✓ |
| Fractogel® EMD TMAE Hicap (M) | 110316 | ✓ | ✓ | ✓ |
| Fractogel® EMD TMAE Medcap (M) | 116885 | ✓ | ✓ | ✓ |
| Fractogel® EMD BioSEC (S) | 110317 | ✓ | ✓ | TBD |
| Fractogel® EMD Chelate (M) | 110338 | ✓ | ✓ | TBD |