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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.

Sartorius 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

  • Ask the Expert: Raw Material Validation

Ask the Expert “Raw Material Validation”

In this ‘Ask the experts’ feature, a panel of key thought leaders, including our Senior Regulatory Affairs & Quality Support Manager, share their perspectives on current obstacles and future developments in raw materials.

Events

Dec 2023
05/12 - 06/12

ATMP Sweden 2023

Uppsala | Sweden