State-of-the-art diagnostics and manufacturing
The IOZK is equipped with two laboratories. A state-of-the-art manufacturing laboratory (GMP) with clean room technology is available for the production of the patient-specific vaccineIO-VAC®. Another focus is the laboratory for research and special immunological diagnostics.
Qualified employees and a special clean room laboratory, in which foreign particles can be excluded as disruptive factors, are two basic requirements for differentiated research and individual immunotherapy. While we develop the patient's own IO-VAC® vaccine in our manufacturing laboratory, the diagnostic laboratory is used for research and special immunological analyses.
The manufacturing laboratory (GMP) must be completely free of germs. This is achieved by means of a positive pressure system with material and personnel airlocks. A continuous flow of air to the outside prevents contaminants from entering the rooms via the air and contaminating the cell cultures. Together with high-quality equipment, these complex installations ensure that the high purity requirements are met.
The highly qualified and specialized team works in accordance with the provisions of the German Medicines Act and the European GMP guidelines (Good Manufacturing Practice).
To produce the patient's own IO-VAC® vaccine, our employees isolate a subgroup of white blood cells, called monocytes, from the patient's blood. These are differentiated into dendritic cells within five to seven days. The IOZK is the only facility in Europe to have a manufacturing license in accordance with §13 AMG for a specific anti-tumor targeted dendritic cell vaccine: dendritic cells derived from monocytes in the patient's blood, loaded with tumor antigens from a lysate of the patient's own tumor cells with immunological danger signals from the Newcastle disease virus.
The IOZK diagnostic laboratory performs complex immunological and molecular genetic analyses. These provide insights into the immune system and tumor of individual patients, which are directly incorporated into the optimization of therapy.
For example, the number and composition of specific subgroups of immune cells can be examined ("quantitative cellular immune status"), the functionality of relevant immune cells ("qualitative cellular immune status") or the antibodies in the blood ("humoral immune status").
Knowledge of the molecular properties of a tumor is essential for targeted therapy. The molecular genetics laboratory at the IOZK is able to detect and analyze tumor components circulating in the blood using liquid biopsy.
