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

  • Our manufacturing sites are ISO 13485–certified
  • FDA-registered and manufacture in conformity with GMP for medical devices, 21 CFR Part 820 
  • 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.

GMP manufacturing

Gibco cell culture products are manufactured in facilities compliant with current good manufacturing practices (GMP) and adhere to a robust quality management system, helping to ensure the consistency, reliability, and high quality you can rely on.
 

Sustainable solutions

We are committed to delivering products that serve the research needs of our customers, while striving to develop them in a way that minimizes our use of natural resources and our impact on the environment.
 

Scaling up

Streamline the path from discovery to cure. Discover cell therapy
solutions for every step.

Resources and support

Resources

Gibco Media Selection Tool
Find the right Gibco media for your application.  Use this interactive tool to select media based upon culture type, components, additives, and format. 

 

Cell Culture Select Tool
Search your cell line of interest to find product recommendations and resources to help enable a successful cell culture.

 

Gibco Cell Culture Basics
Learn best practices and fundamentals of cell culture. Topics include aseptic technique and methods for the growth and maintenance of cells in culture.

 

Cell Culture Videos
Explore this collection of cell culture videos providing valuable insights into techniques, resources, and the latest advancements in the field.

 

Cell Culture & Transfection Learning Center
Access cell culture and transfection educational resources for better experiment planning and execution.

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.

 

Related products

 

For Research Use Only. Not for use in diagnostic procedures.