Regenerative Medicine Utrecht

News

Cell therapy facility fulfills all GMP requirements

Three inspectors from the Healthcare and Youth Inspectorate (IGJ) visited the cell therapy facility (CTF), which is part of the pharmacy, for a GMP inspection (Good Manufacturing Practice). The IGJ regularly checks whether organizations meet the GMP guidelines for producing advanced therapy medicines (ATMPs). They concluded that our CTF works according to these guidelines and can therefore keep the manufacturer’s license.

The two main activities of the CTF are stem cell manipulations (for stem cell transplants) and the production of ATMPs, which are medicines that are used for advanced therapies. An example is the production of mesenchymal stromal cells (MSCs) for the treatment of acute graft-versus-host disease (GvHD). GvHD is a life-threatening side effect of stem cell transplants, in which donor immune cells attack the healthy tissue of the patient.

During two intensive and constructive inspection days, the entire AMTP production process was run from raw materials to the final product delivered to the clinic. The IGJ sees a further positive development compared to previous inspections in 2014 and 2017 and is confident that the CTF will start working with the points for improvement they have suggested. This means that the CTF may retain the GMP manufacturer’s license for ATMPs. Together with the researchers and clinicians involved, the CTF can continue to build on treatments and studies with ATMPs.