Emprove® Cell Culture Media—Comprehensive media component information and risk mitigation
Are you experiencing variability in your cell culture that could be due to unknown impurities or trace elements?
Emprove® Cell Culture Media come with extensive technical, quality, and regulatory documentation to help you identify and mitigate risks efficiently. Our comprehensive Emprove® Dossiers provide in-depth information on composition and raw materials, supporting consistent performance and final product quality.
Save the time and effort needed to compile detailed cell culture media information—access this ready-to-use documentation anytime via our secure online Emprove® Suite platform.
Reduce the burden of collecting extensive information with the Emprove® Cell Culture Media portfolio
Our Cellvento® cell culture media and feeds platform as well as selected EX-CELL® cell culture media are supported by the Emprove® Program. Benefit from:
Transparent composition minimizes unknowns, enabling data-driven decisions and consistent performance
All information for your risk assessment, including origin, trace elements, and stability data
Secure 24/7 access to extensive technical, supply, and regulatory information via our online repository Emprove® Suite
Pioneering cell culture media quality and unmatched transparency
We combine decades of cell culture media experience with continuous innovation. The Emprove® Program delivers extensive documentation reflecting the latest industry standards and regulatory trends, providing you with the information you need for seamless workflows from process development through manufacturing and regulatory approval.
Highlights include:
- We have played an integral role in developing the EXCiPACT® GMP for PAMs standard, with all our existing cell culture manufacturing sites certified to EXCiPACT® GMP by 2025.* You will find detailed information in the Material Qualification Dossier.
- Comprehensive regulatory information including components of interest is featured in the Material Qualification Dossier.
- Supply chain information as well as the Plant Quality Self-Assessment (PQSA) and Supplier Quality Self-Assessment (SQSA) are part of the Quality Management Dossier.
- Information on the raw materials used and, for selected cell culture media, information on trace elements is provided as part of the Operational Excellence Dossier.
Redefining qualification efficiency
Now available: The Emprove® Quality Management Dossier for Custom Cell Culture Media
Qualifying custom cell culture media across multiple manufacturing sites can be time consuming and difficult to manage. It usually requires multi-site audits, site-specific documentation, and repeated follow-ups to gather the information needed. For global manufacturing networks, this can make qualification unnecessarily complex.
Our global manufacturing network for custom cell culture media is built on one global quality system, comparable manufacturing processes, and EXCiPACT® certification. The new Emprove® Quality Management Dossier brings together the relevant information for our six global cell culture media manufacturing sites in a single document. Benefit from:
- One dossier: Streamlined access to critical regulatory and quality information for our entire cell culture media production network.
- Expedited qualification: Qualify our manufacturing network instead of individual manufacturing sites.
Access the new Emprove® Quality Management Dossier for Custom Cell Culture Media for free through the Emprove® Suite, our online repository.
Ensure robust cell culture performance with precise trace element insights
Even slight variations in trace elements can severely impact cell growth, productivity, and product quality—posing an immediate risk to your business consistency. Emprove® Cell Culture Media dossiers provide trace element insights beyond impurity profiles, offering in-depth trace element content data** for full transparency of media composition. This transparency enables a profound understanding of your medium and process, allowing proactive optimization of cell culture conditions. Our stringent control of raw materials and media components ensures that trace element levels remain within a typical range.
Frequently asked questions
What information is provided for Emprove® Cell Culture Media?
The Emprove® Cell Culture Media dossiers include information on the raw material used, trace element data, impurity profiles, regulatory information, thorough quality documentation and more information to support risk assessment and qualification. For a sneak peek, download a Demo Dossier here.
Why is a thorough risk assessment important when selecting cell culture media?
Even small variations in media components or trace elements can impact cell growth, productivity, and final product quality, leading to variability in manufacturing performance. This may severely impact patient safety and business continuity. A robust risk assessment helps identify and mitigate these factors early, enabling improved process understanding and control.
How do Emprove® Dossiers streamline biopharmaceutical workflows?
The Emprove® Dossiers consolidate technical, supply, regulatory, and quality information (including information on raw material origin, trace elements, impurities and more). These extensive documents are easy to use and accessible via our Emprove® Suite online repository, reducing the time and effort needed to collect information for risk assessment, qualification, audit readiness, or the preparation of regulatory filings.
How often are Emprove® Cell Culture Media dossiers updated?
Updates occur as new data becomes available, with continuous expansion of the included information to reflect industry trends, new standards, and regulatory developments. You can opt in to automatic email notifications for the dossiers of your selected Emprove® products in the Emprove® Suite.
How can I access technical, supply, regulatory, and quality information for Emprove® Cell Culture Media?
The Emprove® Suite is our 24/7 accessible online repository for Emprove® Dossiers, providing one centralized source where you can retrieve technical, supply, regulatory, and quality information. This easy access to reliable information helps streamline your workflows, ultimately accelerating development, transfer to manufacturing, and regulatory filing preparation. Register to access Emprove® Suite here.
Which information is available for custom cell culture media to help streamline my qualification efforts?
The Emprove® Quality Management Dossier for Custom Cell Culture Media includes information on quality systems, site layouts, certifications, and capabilities across our global manufacturing network for custom cell culture media, such as:
- CCM manufacturing network including a technology overview
- Supplier and raw material management program
- Trace elements risk categorization
- Non-animal origin and GMO policy
- Quality control standards (validation, transfer)
- Quality and performance review
- Quality risk management and change management process
- Data integrity statement and certifications (ISO 9001 & EXCiPACT certificates)
- Site quality self-assessments
By providing all information in one dossier available as a free download, it helps reduce the effort and accelerate timelines for qualification.
Related resources
- Article: Establishing the first GMP guideline for cell culture media
Cell culture media are vital for bioprocessing therapeutics. This page describes the central role of our organization in authoring purpose-built GMP for cell culture media.
- Article: CHO media and feeds for optimized production of therapeutic proteins
Cellvento® and EX-CELL® CHO cell culture media and feeds, optimized for monoclonal antibody & recombinant protein production in fed-batch & perfusion
- Article: Building regional cell culture media supply chains
Ensure reliable cell culture media supply with our continuously expanding global network of regional sites for resilient biopharma manufacturing.
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*Our new Bioprocessing Production Center in Daejeon, South Korea, is set to open in Q4 2026 and expected to receive certification in accordance with EXCiPACT® GMP standards for Pharmaceutical Auxiliary Materials (PAM) in the course of 2027.
**Currently available for selected media, with ongoing expansion.