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GMP cleanroom laboratory IOZK - Cancer research in the cleanroom

Immuno-oncological therapies treat tumour diseases with individual support of the patients' immune system. In the field of immunological diagnostics, the Immuno-Oncology Centre Cologne researches and develops new methods for cancer treatment. For the sterile production of vaccines, a 100 sqm GMP clean room laboratory was installed in Cologne.

The Immuno-Oncology Centre Cologne (IOZK) has been employing physicians and natural scientists 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 defence system in eliminating cancer cells.

Tobias Geef, the head of purchasing and technology at the IOZK, tries to explain the complex processes of therapy in simple terms:
"We use the biological principles of immunology in our research and develop vaccines that activate the body's defence cells to fight cancer. The immune system is targeted by our vaccine to attack the tumour antigens of its own tumour. The therapy is designed to enable the immune system to become active itself and fight the disease on its own. Ideally, the tumour is completely and sustainably removed by the body's own defences without side effects."

Development of vaccines to fight cancer
In combination with oncolytic viruses that can specifically attack cancer cells, a trend-setting approach is opening up 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 tumour cells and change them. This form of therapy is not yet a treatment standard, but is already available as an individual treatment method for self-pay patients. In the laboratory, 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 here. The production of the patient's own vaccines therefore takes place in a sterile clean room laboratory of the CleanSteriCell brand, which meets the requirements of GMP clean room class B.

Tobias Geef explains the need for the new investment:"The IOZK has several laboratories for research, diagnostics and production. For the production of the patient's own vaccines, we have to comply with the requirements of pharmaceutical manufacturing and the specifications 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 built by SCHILLING ENGINEERING. The limited space and low ceiling height in the existing building presented a particular challenge. The 100 sqm clean room was tailored precisely to these spatial conditions and corresponding ductwork was planned for the air conditioning technology. With over 120 air changes per hour, the supply of clean areas and workplaces with ultra-clean air is ensured according to the principle of low-turbulence displacement ventilation. Filtration is provided by laminar flow units integrated in the ceiling and equipped with ULPA15 high-performance filters. In order to reduce the high energy costs caused by the operation of a clean room, SCHILLING ENGINEERING's system is operated with a particularly energy-efficient recirculation method. A large part of the air discharged from the cleanroom is thereby circulated within the cleanroom walls and reintroduced into the cycle via the filter systems. Since this air is already cooled and particle-reduced, high air-conditioning costs are eliminated. In addition, the filter units clog more slowly and thus have a much longer service life.

GMP monitoring
Workplaces for up to ten employees were set up in the new GMP laboratory. Three personnel and three material locks each, which are operated with different air pressure levels and air changes, ensure the purity 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 necessary monitoring. The control system for the clean room and the air-conditioning technology is the user-friendly CR Control®, with which all setpoints, including the air-conditioning technology, are regulated and monitored and which is controlled via a central touch screen 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 that also has a very long service life.The cleanroom laboratory was qualified by Schilling Engineering in accordance with GMP regulations and handed over ready for operation.

Tobias Geef is very happy about the support of the cleanroom experts:"The qualification of the GMP cleanroom went off without a hitch. There are really a lot of regulations to comply with here, but our cleanroom supplier prepared or approved everything well for us. We have 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, for example, with a GMP-compliant monitoring system, the clearly laid-out control system and the entire furnishings. Now we have a central contact person, also for future maintenance."

This article was published: Laborscope 10-11/2019

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