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GMP Quality

With over 25 years of experience we are experts in the GMP manufacturing of raw materials for the cell and gene therapy space.

CellGenix was the first company to obtain a GMP manufacturing authorization for therapeutic cell processing in Europe. Being an ATMP manufacturer ourselves allowed us to gain in-depth cell culture knowledge and superior regulatory expertise. With this unique background we understand the high requirements you face during product development and the regulatory approval process. We can help simplify your raw material qualificatition and validation efforts by offering expert technical and regulatory support. 

We are able to guarentee a consistent high product quality as all relevant GMP guidelines are followed for each step from initial development to final Quality Control (QC) release after manufacturing.

Our GMP grade raw materials offer a maximum of quality and safety due to state-of-the-art production, stringent quality control and comprehensive documentation.

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Safe │ GMP Compliant │ Reliable 

GMP Quality

With over 25 years of experience we are experts in the GMP manufacturing of raw materials for the cell and gene therapy space.

Our GMP grade raw materials offer a maximum of quality and safety due to state-of-the-art production, stringent quality control and comprehensive documentation.

Read more 

 

News

  • Dec 2020

    How to Standardize Quality Requirements of Raw Materials

    Getting a clear understanding of the materials used in the manufacturing process and regulatory requirements around the quality of raw materials can be challenging. Audits allow cell and gene therapy manufacturers to ensure that the raw material supplier has a clearly defined system for quality monitoring in place. This will help to determine if they are compliant with local and global quality requirements.

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  • Nov 2020

    Novel Serum- and Xeno-free T Cell Medium

    Watch this video to learn more about the advantages of our novel serum- and xeno-free CellGenix® T Cell Medium.

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  • Oct 2020

    CellGenix Completes Facility Expansion to Stay Ahead of the Increasing Demand for GMP Raw Materials

    We are proud to announce the completion of the second phase of our facility expansion. We have reconstructed and expanded our production facility for cytokines and implemented a state-of-the art automated filling and freeze-drying line.

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Events

Apr 2021
06/04 - 09/04

Cell & Gene Meeting on the Meditarranean

Virtual Format (Time Zone CET)
Jun 2021
08/06 - 11/06

Phacilitate: Advanced Therapies Week

Miami, FL | USA