Emprove® Chromatography

High performing resins meet regulatory excellence

Emprove® Dossiers for Purification in Biomanufacturing Process

Any component and raw material used at a later stage of the biomanufacturing process could add a bioburden to the final drug product and is therefore considered a risk. Purity and yield of the target molecule depend heavily on the chromatography steps taken in biomanufacturing processes. For an optimization of the purification process, those steps are essential. The appropriate chromatographic methods need to be selected carefully, as they are specific to the applied process and might be present from early to late downstream. When selecting chromatography methods and products, information is therefore crucial for manufacturers.
 

 Emprove® Dossiers Content

Material Qualification Dossier Quality Management Dossier Operational Excellence Dossier
Material Qualification Dossier Quality Management Dossier Operational Excellence 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. Supports quality risk assessment by offering extended information on quality management system, supply chain, supplier and process evaluation statement, as well as 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.
• General information
• Manufacture
• Quality information
• Specification, release criteria
• Packaging material Regulatory
  statements (BSE/TSE,
  Allergens…)
• Storage and shelf life
• Environmental statement
• Supply chain information
• Product quality self
  assessment
• Supplier and process
  evaluation statement
• Stability data
• Manufacturing process (detailed
  information)
• Elemental impurity information
• Residual solvents statement
• Extractables profile
• Reference spectrum
• Product quality report
• Analytical procedure
Free of charge* 2.000 € 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
 

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

Q2/2020

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