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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*

 
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

5500 €

 
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

3200 €

* 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® 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 €

Target Emprove® dossier for Cellvento® media

Product Article Code Material Qualification Dossier Quality Management Dossier Operational Excellence Dossier
Cellvento® 4CHO-X COMP Expansion 103840 Now Now Now
Cellvento® 4Feed COMP 103796 Q3/2020 Q3/2020 Q3/2020
Cellvento® 4CHO 103795 Q3/2020 Q3/2020 Q3/2020
Cellvento® CHO-200 101885 Q4/2020 Q4/2020 Q4/2020
Cellvento® Feed-200 101883 Q4/2020 Q4/2020 Q4/2020
Cellvento® CHO-220 102577 Q4/2020 Q4/2020 Q4/2020
Cellvento® Feed-220 102578 Q4/2020 Q4/2020 Q4/2020
Cellvento® CHO-210 102485 Q1/2021 Q1/2021 Q1/2021
Cellvento® Feed-210 102488 Q1/2021 Q1/2021 Q1/2021