Emprove® Dossiers for Cell Culture Media in Upstream Processes
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 included in our Emprove® Program.
Dossiers that support upstream productivity, risk assessment, and product quality
As part of the Emprove® Program, cell culture media in our Emprove® CCM portfolio include comprehensive dossiers that facilitate your process optimization, risk assessment, and quality efforts.
Material Qualification Dossier
Quality Management Dossier
Operational Excellence Dossier
Target Emprove® Dossier Availability for Cellvento® Media |
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THE NEW EMPROVE® SUITE: SPEED THROUGH COMPLEXITY WITH CONFIDENCE
Compliance with current Good Manufacturing Practices is a continuum. Changes are inevitable. Audits and periodic reviews are necessary.
Take a seat: The Emprove® Suite is here to improve your risk assessment journey. This Information-as-a-Service digital platform is your co-pilot to support your need for convenient access to reliable information – anywhere, anytime. A subscription helps you stay current: You can not only easily find, view and download Emprove® Dossiers, but also to “opt-in” to notification updates to be informed of changes to documents. You can also generate Emprove® Dossier download metrics and reports, and so much more.
Ultimately, a subscription to the Emprove® Suite empowers you to:
- take advantage of everything the Emprove® Program has to offer
- collaborate and share information globally
- speed your way through the complexity of compliance with confidence
Related Product Resources
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References
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