One of the major control systems to ensure the safety and quality of raw materials1 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.
Click on the circles below to learn more about our GMP quality:
All our preclinical and GMP products are manufactured, tested, released and distributed under an ISO 9001:2008 certified Quality Management System (ISO 9001:2015 is coming soon).
We follow a strict animal-derived component-free (ADCF) and serum-free policy to ensure maximum safety of our preclinical and GMP 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.
1 In the USA raw materials are called ancillary materials