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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

  • Feb 2021

    Why You Shouldn't Rely on One Raw Materials Partner

    What are the prominent challenges with regards to raw materials and automation of raw material processes?

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  • 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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Events

Apr 2021
06/04 - 09/04

Cell & Gene Meeting on the Mediterranean

Virtual Format (Time Zone CET)
May 2021
10/05 - 12/05

18th CIMT Annual Meeting

Virtual Format
 
11/05 - 14/05

ASGCT 24th Annual Meeting 2021

Virtual Format