The aim of the structural harmonization projects is to establish a structure that simplifies collaboration between the core institutions and with external partners.
To this end, two structural harmonization projects have been set up at Fraunhofer CIMD:
Biomaterial Bank
Clinical Research
Find out more about the two projects below.
For more information:
High-quality and comparable biosamples are the basis for good medical research. The quality of cryopreserved samples has a significant influence on the results, especially of biomarker-based analyses or, as is often the case in immunological research, when examining living cryopreserved cells. The medical-scientific value of biosamples also depends heavily on their availability and the associated health data of the donors and can be increased by harmonized SOPs (Standard Operating Procedures), optimized data management and optimized sample management.
To meet the above requirements, the biomaterial banks of the Fraunhofer institutes for Translational Medicine and Pharmacology, for Toxicology and Experimental Medicine and for Cell Therapy and Immunology have been harmonized and a central Fraunhofer CIMD biobank infrastructure has been created. The high quality and comparability of the stored samples is ensured by harmonized SOPs and quality assurance structures, as well as by the application of high biobanking standards based on the German Biobank Alliance (GBA) and the Technology and Methods Platform for Networked Medical Research (TMF). Ethical and data protection requirements were harmonized and a scientific Use and Access Committee was established. The sample stocks of the three institutes were combined in a central sample database, thus facilitating sample visibility and sample selection.
Currently, the central sample database stores around 16,000 biosamples from 550 patients (mainly with asthma, allergy and COPD, as well as from healthy donors) (see Fig. 1). The samples come from Fraunhofer CIMD biobank collections and from former collections of the partner institutes. Further collections will be integrated in the near future.
The established biobank infrastructure can be used by interested Fraunhofer institutes to establish or improve biobanking activities in a time- and resource-efficient manner. This allows them to access modern and high-quality biobanking procedures.
The samples collected by the Fraunhofer CIMD Biobank can be used for studies or scientific projects after application to the Fraunhofer CIMD Biobank steering committee.
If you are interested, please send us an email.
Fraunhofer Institute for Translational Medicine and Pharmacology ITMP
Fraunhofer Institute for Toxicology and Experimental Medicine ITEM
Fraunhofer Institute for Cell Therapy and Immunology IZI
Hannover Unified Biobank (HUB), Hannover Medical School (MHH)
Contact person: Dr. Sonja Volland, Fraunhofer ITEM, Hannover Unified Biobank (HUB)
Fraunhofer ITMP: Dr. Stephanie Dauth, Hannah Kratz, Dr. Michaela Köhm, Katrin Donde.
Fraunhofer ITEM: Dr. Meike Müller
Fraunhofer IZI: Claudia Müller, Alexander Dossin
Harmonized structural development of clinical research within the framework of the Fraunhofer CIMD
The use of electronic systems, such as a clinical trial management system, an electronic trial master file or an electronic QM document management system, enables a standardized organization of documents that meets regulatory requirements. The standardized use of these systems ensures consistent quality of document storage and processing. By harmonizing processes based on a common system, synergies can be achieved at the core institutions through standardized training, operations, quality and validation. The creation of synergies aims not only to increase quality as a feature for cooperation partners and clients, but also to save costs.
Since the core institutes of the Fraunhofer CIMD are active in clinical research in different sections of health research and therefore have to meet different requirements of clients and regulatory authorities, systems are to be identified in which harmonization can lead to synergies. Currently, the market offers a variety of electronic systems that could be used in the context of projects in the highly regulated GxP (good work practice) area. The systems offer a variety of functions. The selection of the system must be based on the project-specific and institute-specific requirements, as well as data protection and Information Security.
Each core institute has an institute branch, project group or several working groups that have been dealing intensively with various clinical research questions or commissions for years. The aim of this project is to simplify the implementation of joint projects and industrial collaborations in the clinical research section of Fraunhofer CIMD. To this end, a structure is being established that simplifies collaboration between the core institutes and with external partners.
Our goal is to carry out projects in a controlled and standardized manner while creating synergies. To achieve this, we must first select suitable systems that ensure consistent quality at all participating core institutes. To do this, we must first identify systems that, when established and harmonized with the respective processes, represent an increase in quality and create synergies.
The expertise of the institutes in conducting projects in the highly regulated section of Good X Practice (GxP), such as Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP), is used in this project. All institutes base their actions on these internationally applied guidelines. This makes it possible to assess the introduction and the properties of a new electronic system for the standardized, quality-controlled and quality-promoting implementation of (study) projects based on the institutes' many years of expertise.
As part of the project, systems such as electronic data capture systems or systems for controlling quality documents are analyzed and possibilities for harmonization are identified. The systems should enable standardized, quality-controlled workflows, as well as simplify and optimize processes. This will allow synergies to be realized and enhance the quality of the partner institutes' projects.
Fraunhofer Institute for Translational Medicine and Pharmacology ITMP
Fraunhofer Institute for Cell Therapy and Immunology IZI
Fraunhofer Institute for Toxicology and Experimental Medicine ITEM
Dr. Tanja Roßmanith (project manager), Fraunhofer ITMP
Fraunhofer ITEM: Prof. Jens Hohlfeld, Dr. Philipp Badorrek
Fraunhofer IZI: PD Dr. Stephan Fricke, Dr. André-René Blaudszun, Mirko Müller
Fraunhofer Cluster of Excellence Immune-Mediated Diseases