Quality assurance at the Fraunhofer IBMT is one of the main pillars of customer service at a high level. In carrying out its work, the Fraunhofer IBMT has the claim to carry out its projects at the highest quality level and commits itself to work according to the rules of “good professional practice”. The quality system has been set up according to different standards, principles and guidelines. The trustful cooperation between the institute and its customers/project partners at the highest scientific level is confirmed by the realization of a transparent QM program in which all levels are involved. For this reason, in 2008, the Fraunhofer IBMT began to set up a quality management system and to have specific projects or facilities certified. The Quality Management System and all processes in the Medical Biotechnology Main Department are defined in standard operating procedures (SOPs). These documents are constantly updated and our quality management system is regularly audited by authorities and certification/accreditation bodies and checked for effectiveness.
GLP-certified laboratories for pioneering technologies
Since mid-February 2019, the laboratories of the Main Department of Medical Biotechnology in Sulzbach are now also GLP certified. In Saarland, the Ministry of the Environment and Consumer Protection is responsible for issuing a GLP certificate in accordance with § 19b (1) of the Chemicals Act.
The Medical Biotechnology Main Department develops advanced technology platforms for collecting, preparing, preserving, and distributing bioreagents and clinical samples for worldwide networks. These include optimized sample processing and cryopreservation processes as well as the production of bioreagents. The Main Department provides new technology platforms for the development and clinical testing of vaccines and new therapies, such as e.g., virus stocks can be manufactured in a fully automated facility. This includes the operation of various biobanks. Since 2012, the human area of the Federal Environmental Specimen Bank (UPB) has been operated as an important biobank at the Fraunhofer IBMT. This is an archive of human samples, which as part of the Federal Environmental Specimen Bank is a central element of the Federal Republic of Germany for the risk assessment of pollutants in humans, the so-called human biomonitoring.
Four facilities DIN EN ISO 9001: 2015 certified
As early as May 2017, four facilities at the Fraunhofer IBMT were successfully certified by GZQ according to the DIN EN ISO 9001: 2015 standard:
The HIV Specimen Cryorepository (HSC) facility provides a standardized production of virus stocks for HIV research. The area has developed historically through collaboration with the CAVD (Collaboration for AIDS Vaccine Discovery), an initiative funded by the Bill & Melinda Gates Foundation. Since the research viruses produced at the Fraunhofer IBMT are used worldwide, the production and storage of the viruses has been certified since 2008 according to the „Good Clinical Laboratory Practice“ (GCLP) standard in order to guarantee the highest quality of the work.
At the same time, the storage of samples from other research projects at the IBMT with the Cryobank Saarbrücken facility (KBSB) was also placed under a quality management system.
The Stem Cell Laboratory (SZL) with its project „European Bank for Induced Pluripotent Stem Cells (EBiSC)“ is a project funded by the European Innovative Medicines Initiative (IMI) and provides scientists with access to quality-controlled, disease-relevant induced pluripotent stem cells, data and research-grade cell services.
The Federal Environmental Specification Bank (UPB) of the Fraunhofer IBMT has been in charge of the human area of the Federal Environmental Specimen Bank (UPB) since January 2012 on behalf of the Federal Environmental Agency. In addition to certification according to DIN EN ISO 9001:2015, this facility is also accredited as a Test Laboratory according to DIN EN ISO/IEC 17025:2005. The UPB is a central element of integrated environmental monitoring in Germany. It is understood to mean the collection and modification-free storage of representative biotic and abiotic samples over a period of at least several decades for later, retrospective analyzes. The UPB archives irretrievable environmental and human samples and their information content about the state of the environment. The UPB is a permanent task of the Federal Government under the overall responsibility of the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety (BMU) and the technical and administrative coordination of the Federal Environment Agency (UBA). For more than 30 years, it has provided the BMU with an important scientific basis for taking action in environmental protection and nature conservation and in controlling its success.
The Fraunhofer IBMT has the following certifications & accreditations:
• GLP certification (Good Laboratory practice)
• DIN EN ISO 9001: 2015
• GCLP certification (Good Clinical Laboratory Practice)
• DIN EN ISO/IEC 17025:2005
contact for scientific information:
Prof. Dr. Hagen von Briesen
Head of Main Department Medical Biotechnology
Tel: +49 (0) 6897/9071-286