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.  

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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

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, etc.) 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.

Quality Management Dossier

Supports risk assessment activities by offering extended information on the quality management system applied and supply chain information. It also contains media stability data.	Supply chain information Product quality self-assessment Site quality self-assessment Supplier management Stability data

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.	Trace element information Origin of raw materials Analytical procedure

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

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

Tool: Risk Mitigation and Quality Requirements: Support for Bioprocesses
Brochure: Ease your regulatory efforts with Cellvento^® CHO media

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Emprove^® Categories

The Emprove® Program contains over 400 raw and starting materials as well as 20 filter and single-use product families.

Emprove^® Dossiers

Emprove® Dossiers provide comprehensive, up-to-date documentation to help you navigate regulatory challenges, manage risks, and improve your manufacturing processes.

Emprove^® Learning

Each product portfolio is supported with Emprove® Dossiers which provide comprehensive, up-to-date documentation to help you navigate regulatory challenges, manage risks, and improve your manufacturing processes.

To subscribe today, simply complete and submit the reply form below after reading our Emprove^® terms and conditions.

References

1. Sept. 2019. Raw Material Risk Assessments – A Holistic Approach to Raw Material Risk Assessments through Industrial Collaboration. BioPhorum.

2. Dec. 2018. Management and Control of Raw Materials Used in the Manufacture of Biological Medicinal Products and ATMPs. European Biopharmaceutical Enterprises.