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Emprove® Program > Emprove® CCM
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Emprove® CCM

Ease your regulatory efforts with Cellvento® CHO media

 

Emprove® Dossiers for Cell Culture Media in Upstream Processes

Emprove® Dossiers for Purification in Biomanufacturing Process

Cell culture media (CCM) drive the productivity of upstream processes and help ensure critical quality attributes of the final drug product. Because of this critical role in manufacturing, along with increased regulatory focus on raw materials, it is recommended that media be included in drug product risk assessments.1,2

To ease the burden of collecting the extensive information needed for a thorough assessment, Cellvento® CHO cell culture media are now included in our Emprove® Program.

  1. BioPhorum “Raw material risk assessments – A holistic approach to raw materials risk assessments through industry collaboration”, Sept 2019.
  2. European Biopharmaceutical Enterprises, “Management and control of raw materials used in the manufacture of biological medicinal products and ATMPs”, Dec 2018.

Emprove® Dossiers Content

 
Emprove - Material Qualification Dossier

Material Qualification Dossier

Speeds up media qualification and supports regulatory filing preparation. It includes information on the manufacturing process and media homogeneity.
Furthermore, it includes regulatory certificates, example certificates of analysis, shelf life information and more.

  • General information
  • Specification
  • Manufacture
  • Homogeneity statement
  • Regulatory statements (BSE/TSE, Allergens, Components of Interest…)
  • Packaging Material

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.

 
Emprove - Quality Management Dossier

Quality Management Dossier

Supports risk assessment activities by offering extended information on the quality management system applied and supply chain information. It contains also media stability data.

Demo Dossier

  • Supply Chain Information
  • Product Quality Self Assessment
  • Site Quality Self Assessment
  • Supplier Management
  • Stability Data

 
Emprove - Operational Excellence Dossier

Operational Excellence Dossier

Supports process optimization efforts. It contains information on typical levels of trace elements, information on origin of raw materials used, as well as analytical procedures.

Demo Dossier

  • Trace Element Information
  • Origin of Raw Materials
  • Analytical procedures

Emprove® Suite Subscription

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

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  • One-time registration
  • 24/7 full online access
  • 1 or 2-year subscriptions

Target Emprove® dossier for Cellvento® media

Product Article Code Material Qualification Dossier Quality Management Dossier Operational Excellence Dossier
Cellvento® 4CHO-X COMP 103840
✓
✓
✓
Cellvento® 4Feed COMP 103796 New New New
Cellvento® 4CHO 103795 New New New
Cellvento® CHO-200 101885 New New New
Cellvento® Feed-200 101883 New New New
Cellvento® CHO-220 102577 New New New
Cellvento® Feed-220 102578 New New New
Cellvento® CHO-210 102485 New New New
Cellvento® Feed-210 102488 New New New