GMP Quality

Good Manufacturing Practice

One of the major control systems to ensure the safety and quality of raw and ancillary materials is Good Manufacturing Practice (GMP). We are able to guarantee a consistently high product quality as we follow all relevant GMP guidelines for each step from initial development to final Quality Control (QC) release after manufacturing.

To facilitate a seamless transition from early development to the clinical stage and commercial manufacturing of ATMPs, we offer both preclinical and GMP cell culture reagents which have the same main product characteristics.

 

All our preclinical and GMP products are manufactured, tested, released and distributed under an ISO 9001:2015 certified Quality Management (QM) system.

We follow a strict animal-derived component-free (ADCF) and serum-free policy to ensure maximum safety of our preclinical and GMP grade raw materials. As a result no animal or human-derived components are part of any of our cytokine products. All our media are produced without the addition of human or animal serum.

Sartorius CellGenix GMP Quality

Preclinical vs GMP

From Preclinical Development to ATMP

ADCF & Serum-free Policy

Regulatory Support