The Immuno-Oncology Center Cologne (IOZK) has been employing doctors and scientists who have been researching the role of the immune system in cancer since 1985. The oncological immunotherapies developed from this research aim to support the body’s own defense system in eliminating cancer cells.
Tobias Geef, Head of Purchasing and Technology at the IOZK, tries to explain the complex processes of the therapy in simple terms:“In our research, we use the biological principles of immunology and develop vaccines that activate the body’s defense cells to fight cancer. Our vaccine directs the immune system precisely to the tumor antigens of the patient’s own tumor in order to attack it. The aim of the therapy is to enable the immune system to become active and fight the disease on its own. Ideally, the tumor is completely and sustainably removed by the body’s own defenses without any side effects”
Development of vaccines to fight cancer
The combination with oncolytic viruses that can specifically attack cancer cells opens up a pioneering approach in the fight against cancer that drastically reduces the side effects of treatment. The IOZK has received approval to develop combination substances that are mixed with specific viruses. The vaccines penetrate the tumor cells and change them. This form of therapy is not yet a standard treatment, but is already available as an individual treatment method for self-payers. In the laboratories, human cells are made to grow in special nutrient fluids and at body temperature. Foreign particles as interfering factors and any germ contamination must be excluded. The production of the patient’s own vaccines therefore takes place in a sterile CleanSteriCell cleanroom laboratory that meets the requirements of GMP cleanroom class B.
Tobias Geef explains the necessity of the new investment:
“The IOZK has several laboratories for research, diagnostics and production. For the production of patient-specific vaccines, we have to comply with the requirements of pharmaceutical manufacturing and the provisions of the German Medicines Act. We have now invested in a brand new manufacturing laboratory with clean room technology. The cleanroom system complies with cleanroom class GMP B, is energy-efficient and state-of-the-art, which was important to us”
State-of-the-art, energy-efficient cleanroom system
The cleanroom laboratory was planned and constructed by SCHILLING ENGINEERING. The limited space and low ceiling height in the existing building posed a particular challenge. The 100 square meters Cleanroom were tailored precisely to these spatial conditions and corresponding ductwork for the air conditioning technology was planned. With over 120 air changes per hour, the supply of clean areas and workstations with ultra-pure air is ensured according to the principle of low-turbulence displacement ventilation. Filtering takes place via laminar flow units integrated into the ceiling, which are fitted with ULPA15 high-performance filters. In order to reduce the high energy costs associated with operating a clean room, the SCHILLING ENGINEERING system is operated using a particularly energy-efficient air recirculation process. A large proportion of the air extracted from the Cleanroom is circulated within the cleanroom walls and reintroduced into the cycle via the filter systems. As this air is already cooled and particle-reduced, there are no high air conditioning costs. In addition, the filter units clog more slowly and therefore have a much longer service life.
GMP monitoring
Workstations for up to ten employees have been set up in the new GMP laboratory. Three personnel and three material airlocks each, which are operated with different air pressure levels and air changes, ensure the cleanliness of the laboratory facility up to GMP class B. A special feature of the cleanroom laboratory is the integrated GMP-compliant monitoring. Particle count, temperature, humidity and air pressure are permanently monitored and recorded for the required monitoring. The user-friendly CR Control® serves as the control system for the Cleanroom and the air conditioning technology, with which all set values including the air conditioning technology are regulated and monitored and which is controlled via a central touchscreen and also mobile.
The CleanSteriCell® cleanroom system has a modular design and can be flexibly extended and converted thanks to a patented silicone-free GMP sealing clip system. GMP-compliant LED light strips provide pleasant and energy-saving lighting, which also have a very long service life, and the cleanroom laboratory was qualified by Schilling Engineering in accordance with GMP regulations and handed over ready for operation.
Tobias Geef is very pleased with the support from the cleanroom experts:
“The qualification of the GMP cleanroom went without a hitch. There really are a lot of regulations to comply with here, but our cleanroom supplier prepared everything well for us or approved it. We have now just gone into production and are very satisfied with the processes. A big plus is that Schilling Engineering was able to offer us a complete package for the cleanroom laboratory. In addition to the actual Cleanroom and air-conditioning technology, we were supplied with a GMP-compliant monitoring system, a clear control system and all the furniture. We now have a central point of contact, also for future maintenance.”
This article was published: Laborscope 10-11/2019
