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In with the new
BERLIN & AACHEN, Germany—RWTH Aachen University has been working on the development of what are being called biohybrid implants—implants that are partly made from artificial materials and partly from the body’s own cells, utilizing a combination of cells in a biological matrix and a textile reinforcement that helps ensure the implants’ reliability and sustainability. The biomaterials are first processed into textile structures using traditional textile techniques such as knitting, melting and electrospinning, then colonized by the cells using fibrin, which aids in functions such as blood coagulation. Once heart valves are produced this way, they are trained in a bioreactor for the natural blood flow and pressure occurring in the body before they are ready to be implanted.
Currently, the focus is on preclinical studies. However, the aim is to further test the results in clinical studies as well, which leads to challenges in data collection and analysis.
“When you do research that is so close to clinical application, and everything is aimed at testing the results in human patients, you have to ensure the quality and traceability of the preclinical research data for all participants,” comments Prof. Christian Apel, head of the Biohybrid and Medical Textiles department at the University. “Both the ‘good scientific practice’ and the regulatory authorities demand a complete record and safe storage of our research results. Of course, as a university institution, we also have many students and postgraduates who contribute a big deal to research. However, they leave the institute after completing their project, which is not only a great pity, but also very frustrating to see data generated with great effort become irretrievable, hidden in paper notebooks or in unstructured or even inaccessible digital documents.”
To tackle this challenge, RWTH researchers have opted for an electronic lab notebook (ELN) called labfolder from the eponymous company labfolder GMBH. Founded in 2013 by molecular biologist Simon Bungers (CEO) and biophysicist Florian Hauer (chief operating officer)—and joined later by Yannick Skop (chief commercial officer) and Mario Russo (chief technology officer), labfolder’s software-as-a-service (SaaS) makes it easier for researchers and supporting scientists to record, retrieve, share, discuss and validate research data as a team. To date, labfolder is used by more than 16,000 international scientists in all disciplines, as well as by industrial and pharmaceutical scientists in R&D, analysis and production labs.
The software streamlines utilities such as drag-and-drop data integration available on any computer or mobile device, access to Word and Excel documents and customizable entry forms. Teams are able to strategize and optimize their workflow, discuss and collaborate within the program and designate administrative controls. Additionally, labfolder can be integrated with apps such as Dropbox or the labfolder app itself, and is functional across all platforms and operating systems.
In terms of integrity and security, labfolder’s SaaS ELN software offers full version histories and time stamps, a sign-and-witness app and free daily backup to the cloud. Users retain all ownership of data loaded to the program, and nothing can be accessed unless it has been specifically shared to a team. In addition, labfolder meets all requirements for the fully compliant usage in GxP certified laboratories being compliant to the requirements for electronic recording according to both good laboratory practices and good manufacturing practices. The program also meets all requirements for the fully compliant usage in laboratories which are certified according to ISO standards ISO 9001, ISO 13485, ISO 15189 and ISO 17025 and facilitates the transition to ISO quality management systems.
“Of course, it’s great fun to work with pioneers who share our vision,” said labfolder’s Hauer. “Sooner or later, the lab book will become an intelligent lab assistant.”
The labfolder decision coincides with the opening of RWTH’s new Center for Biohybrid Medical Systems (CBMS) within the biomedical engineering cluster in January of this year. The new center, led by Prof. Dr. Stefan Jockenhövel, will not only provide a new building infrastructure, but also a digital infrastructure from day one.
“Once you have convinced employees to store all your data in a structured and accessible way, and this data treasure trove grows constantly, then previously unimagined possibilities open up for us in the future,” says Apel. “Every scientist dreams of getting as much out of his data as possible. We produce so much data that a human cannot possibly perceive all the potential relations within the datasets.”