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Gibco Media GMP Quality
High-quality GMP-compliant products
As a leader in quality, innovation, and capacity, we are dedicated to operational excellence in everything we do—from how we manage our core quality processes to our facility investments and our risk management systems. Gibco media products are manufactured according to good manufacturing practices (GMP) to help ensure product performance.
Quality comes first and the proof is in our performance
Manufacturing Gibco media and reagents since 1962
Supplying the top 50 biopharmaceutical companies worldwide with solutions that drive success
Over 200,000 publication references and counting
We have been delivering GMP-compliant media for over 30 years
Key benefits:
Ensures the consistency, reliability, and high quality of our Gibco cell culture reagents.
Our global GMP manufacturing capabilities
Delivering continuity of supply with the highest-quality products to all of our customers globally.
Our registered ISO-certified and state-of-the-art facilities are strategically located around the world to support our customers.
Quality and safety
The focus on quality and consistency enables us to help our customers achieve their goals.
Commitment to quality
We are committed to your success. By maintaining a standard of unassailable quality and continuous process improvement, our quality management systems and policies are designed to meet your ever-changing needs. We know how critical product quality is to your success, which is why we are committed to thorough documentation, design control, and extensive QC testing.
Quality management systems
Our stringent management controls, process controls, and built-in process improvement steps ensure we meet the quality standards that you expect. We aim to meet quality and regulatory standards and to exceed customer expectations in all that we do. At Thermo Fisher Scientific, we welcome customer and supplier audits as a way to ensure our quality standards meet the expectations and ever-changing needs of our customers.
Quality control testing–validated processes and test methods
All of our CTS products meet the minimum quality control requirements as outlined in USP <1043> (ancillary materials for cell, gene, and tissue-engineered products) and Ph. EUR 5.2.12 (raw materials of biological origin for the production of cell-based and gene therapy medicinal products).
Gibco Cell Therapy Systems (CTS) media and reagents undergo extensive QC testing following pharmacopeia test methods where possible. Our routine QC on all CTS reagents includes:
- Sterility (for aseptic products only) or Bioburden Testing
- Mycoplasma
- Performance testing based on the intended use
- Real time stability with meaningful stability indicating tests
Our biological origin raw material traceability, quality control testing and test method references are detailed on our Certificates of Analysis and Origin. These documents are designed to enable risk assessment of CTS products for use in clinical manufacturing. All CTS products have SDS available.
Commitment to quality
We are committed to your success. By maintaining a standard of unassailable quality and continuous process improvement, our quality management systems and policies are designed to meet your ever-changing needs. We know how critical product quality is to your success, which is why we are committed to thorough documentation, design control, and extensive QC testing.
Quality management systems
Our stringent management controls, process controls, and built-in process improvement steps ensure we meet the quality standards that you expect. We aim to meet quality and regulatory standards and to exceed customer expectations in all that we do. At Thermo Fisher Scientific, we welcome customer and supplier audits as a way to ensure our quality standards meet the expectations and ever-changing needs of our customers.
Quality control testing–validated processes and test methods
All of our CTS products meet the minimum quality control requirements as outlined in USP <1043> (ancillary materials for cell, gene, and tissue-engineered products) and Ph. EUR 5.2.12 (raw materials of biological origin for the production of cell-based and gene therapy medicinal products).
Gibco Cell Therapy Systems (CTS) media and reagents undergo extensive QC testing following pharmacopeia test methods where possible. Our routine QC on all CTS reagents includes:
- Sterility (for aseptic products only) or Bioburden Testing
- Mycoplasma
- Performance testing based on the intended use
- Real time stability with meaningful stability indicating tests
Our biological origin raw material traceability, quality control testing and test method references are detailed on our Certificates of Analysis and Origin. These documents are designed to enable risk assessment of CTS products for use in clinical manufacturing. All CTS products have SDS available.
Scaling up
Streamline the path from discovery to cure. Discover cell therapy solutions for every step.
GMP manufacturing services
We offer tailored media manufacturing services to suit your research needs. Outsource the manufacturing of your own cell culture media formulation and benefit from supply assurance, consistent quality, and our global site equivalency.
Sustainable solutions
The 1 L Gibco bottle uses 38% less source material (32% less material for the 500 mL bottle) than comparable media bottles on the market today. This helps reduce the consumption of non-renewable resources, helping shrink your footprint.
Download the Green Fact Sheet
Learn more about sustainable solutions
Resources
Cell Culture & Transfection Learning Center
Access cell culture and transfection educational resources for better experiment planning and execution.
Gibco Cell Culture Basics
Learn the fundamentals of cell culture for achieving consistent results, including laboratory setup, safety, and aseptic techniques.
Media Formulation Tool
Find the right Gibco media formulation for DMEM, DMEM/F-12, MEM, and RPMI-1640 media.
Related products
Support
Cell Culture & Transfection Support Center
Find technical support recommendations for your cell culture and transfection workflows, including tips for experimental setup and in-depth troubleshooting help.
Need technical support? Contact our expert team for technical and application support of Laboratory Products.
Intended use of the products mentioned on this page vary. For specific intended use statements please refer to the product label.
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