Our Quality
Our Quality
We are a socially responsible CDMO, specializing in the manufacturing of cellular medicinal products on behalf of various entities conducting their projects and clinical trials, as well as for individual therapies prescribed to treat specific patients.
Regardless of the purpose of our production, we consistently maintain the highest quality standards. Throughout our work, we remain deeply aware that the medicines we produce will ultimately be administered to patients in need.
Our commitment to quality standards is guided by the legislation of the European Union, implemented in each member state and reflected in our Good Manufacturing Practice (GMP) system.
The principles of GMP include all aspects related to the production of cellular therapy products: from facility design and equipment quality to infrastructure oversight, production processes, quality control, and the final release of the product for human use.
We Are Subject to Supervision and Regularly Inspected by Competent Authorities.
When our products are intended for clinical trials, they undergo expert evaluation through the unified EU Clinical Trials Information System (CTIS).
It is also worth noting that any experimental application of cellular therapy products in humans must first receive a positive opinion from an ethics committee.