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.
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.
News
Urgently Seeking Simplicity
Cell and Gene Therapy opens up new perspectives and gives patients new hope, when there is no other therapy option anymore. But developing and manufacturing is challenging: It is complex, expensive and time-consuming. It is [...]
Drug Master File for CellGenix® GMP TCM
We are pleased to announce the submission of a Drug Master File (Type II) to the US FDA (CBER) for CellGenix® GMP TCM. As for our other GMP products this Master File can be cross-referenced [...]
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