What we offer
We offer state-of-the art preparation of a variety of cellular products with highly qualified personnel. We participate in translational research and in the development and optimization of novel cell culture techniques.
Techniques
- processing of hematopoietic stem and progenitor cells
- cell isolations and expansion in closed systems
- magnetic cell sorting using CliniMACS
- loading of dendritic cells with RNA
- cryopreservation with Planer®freezers
- storage of cellular products in the vapour phase of liquid nitrogen
- thawing of cellular products for clinical use
- progenitor cell assays
- quality control assurance
Regulation
The processing of bone marrow or mobilized pheripheral blood derived hematopoietic stem and progenitor cells and donor lymphocytes is performed according to JACIE standards and the Laboratory is acknowledged by the Dutch Ministry of Health with an 'orgaanbank erkenning' in accordance with the 'Wet Veiligheid en Kwaliteit Lichaamsmateriaal' and the EU guideline 2004/23/EC.
Manufacturing of cellular products or so-called Advanced Therapy Medicinal Products has to meet the most stringent requirements with regard to the production process, to ensure the highest safety of the end product. The European Community has defined the standards in directive EC/1394/2007 with respect to the ATMPs and directive 2001/83/EC and guideline 2001/83/EC on all aspects, including GMP of human medicinal products. For the production of ATMPs in The Netherlands approval by the CCMO or the Inspection of Health is obliged.
More information can be found on the website of Eudralex.
We can take care of all registration and documentation concerning the production of ATMPs for your clinical trial.
