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GMP Quality

With over 20 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 20 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

  • Aug 2018

    CellGenix ISO 9001:2015 re-certified

    CellGenix has successfully met the requirements defined in DIN EN ISO 9001:2015. By meeting the extensive criteria for this quality standard, CellGenix affirms its commitment to quality and service.

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  • Aug 2018

    6th “Expert Symposium on Chances & Challenges of cell-based therapeutics”

    Successful 6th “Expert Symposium on Chances & Challenges of cell-based therapeutics” organized by CellGenix

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  • Jun 2018

    Press Release CellGenix - June

    CellGenix Completed First Step of Facility Expansion to Stay on Top of the Increasing Demands for GMP Cell Culture Reagents

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