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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

  • Nov 2018

    CellGenix Appoints Dr. Udo Nirenberg as Vice President Quality Management and Member of the Management Team

    CellGenix, a global manufacturing leader of GMP-grade raw materials for cell therapy, gene therapy and tissue-engineered products, is pleased to announce the appointment of Dr. Udo Nirenberg as Vice President of Quality Management and member of the management team.

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  • Oct 2018

    Make your next career step and apply for a CellGenix stipend!

    CellGenix is proud to support a novel Master program in Manufacturing of Advanced Therapy Medicinal Products organized by the Andalusian Initiative for Advanced Therapies and the University of Granada with the collaboration of the Línea IAVANTE ‐ Progress and Health Foundation.

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  • 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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