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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

  • 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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  • Jun 2020

    Overcoming Raw Material Challenges in Cell and Gene Therapy Manufacturing

    At Phacilitate Leaders World 2020 in Miami CellGenix led a breakfast briefing to discuss the challenges the advanced therapies industry is facing when it comes to raw materials.

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  • Jun 2020

    Panel Discussion: Current obstacles in allogeneic CAR-T development and possible future evolution

    Our Head of R&D Cell Culture Systems, Ulla Schultz, recently joined a panel discussion focusing on the challenges faced by cell therapy manufacturers in the development of allogeneic CAR-T. You can now watch it on demand.

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Events

Oct 2020
26/10 - 28/10

Allogeneic Cell Therapies Summit

Virtual Format
Nov 2020
02/11 - 05/11

Next Generation CAR & T Cell Therapies

Virtual Format (Time Zone PST)
 
05/11 - 07/11

4th Cell Therapy Symposium

Heidelberg | Germany