Emprove® Program > Emprove® Chromatography
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Emprove® Chromatography

High performing resins meet regulatory excellence

 

Emprove® Dossiers for Purification in Biomanufacturing Process

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

 
Emprove - Material Qualification Dossier

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*

 
Emprove - Quality Management Dossier

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.

Demo Dossier

  • Supply chain information
  • Product quality self assessment
  • Supplier and process evaluation statement
  • Stability data

2.000 €

 
Emprove - Operational Excellence Dossier

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.

Demo Dossier

  • Manufacturing process (detailed information)
  • Elemental impurity information
  • Residual solvents statement
  • Extractables profile
  • Reference spectrum
  • Product quality report
  • Analytical procedure

6.700 €

* 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.

** Status May 2020

Emprove® Suite Subscription

Unlock Full Access to all dossiers today with the Emprove® Suite Subscription.

Subscribe
  • One-time registration
  • 24/7 full online access
  • Subscription period 1, 2 or 5 years
  • 1 year: 11.000 €
  • 2 years: 22.000 €
  • 5 years: 50.000 €

Products in scope for 2020

Product Catalog Number Material Qualification Dossier Quality Management Dossier Operational Excellence Dossier
Eshmuno® Q 1.20079 Now Now Now
Eshmuno® CPX 1.20083 Now Now Q4/2020
Eshmuno® S 1.20078 Now Now Q4/2020
Eshmuno® HCX 1.20087 Q3/2020 Q3/2020 2021
Eshmuno® CMX 1.20650 Now Q3/2020 2021
Fractogel® EMD SO3 (M) 1.16882 Q3/2020 Q4/2020 2021
Fractogel® EMD TMAE (M) 1.16881 Q3/2020 Q4/2020 2021
Fractogel® EMD TMAE (S) 1.16887 Q4/2020 Q4/2020 2021
Fractogel® EMD TMAE Hicap (M) 1.10317 Q4/2020 Q4/2020 2021