Pure, purer, purest

The female researchers from Turkey's Necmettin Erbakan University (NEU) and the team from the Chair of Tissue Engineering and Regenerative Medicine are ready to visit the cleanrooms. A visit as part of the EU project REGENEU. (Image: Kirstin Linkamp, UKW)

As part of the EU project REGENEU, a Turkish delegation visited the cleanrooms of the University Hospital Würzburg (UKW) and received training from Privatdozent Dr. Oliver Pullig and his team on Good Manufacturing Practice (GMP).

How do I put on a cleanroom suit without touching the floor? What should I consider at the airlocks? And how does my material move from C to B? These and more questions were literally experienced firsthand by Turkish female doctors and scientists from Necmettin Erbakan University (NEU) in Konya today at the University Hospital Würzburg (UKW). They donned coveralls and learned about the cascade system of a cleanroom — from the contaminated side, the gray area, through various stages from D to B, where entry is no longer permitted in white but only in blue coveralls. It only becomes cleaner under the workbench, in area A, where open product work takes place.

For example, on cartilage tissue taken from patients' noses to produce an implant for cartilage defect regeneration in the knee under strict aseptic conditions (Info). Since the implant consists of living cells, it is classified as a medicinal product for advanced therapies, abbreviated as ATMP (Advanced Therapy Medicinal Products). This means it is subject to special regulations. And for these, Privatdozent Dr. Oliver Pullig from the Chair of Tissue Engineering and Regenerative Medicine (TERM) at UKW is an expert.

"GMP-compliant Implant Development"

Together with his colleague Dr. Sarah Nietzer, he leads the working group "GMP-compliant Implant Development" in the EU project REGENEU. GMP stands for Good Manufacturing Practice, which refers to quality assurance guidelines for production processes and environments (Good Manufacturing Practice = GMP). REGENEU is a three-year project within the framework of the Horizon Europe research and innovation program, in which UKW, the Fraunhofer Society, the Royal College of Surgeons in Ireland (RCSI), and Trinity College Dublin (TCD) support NEU in various formats to enhance their scientific expertise and excellence in biofiber research and development for translational applications.

Just a few weeks ago, in April 2024, the two visited Konya, Turkey's million-city, to conduct training at various NEU locations. They covered the spectrum of GMP from regulatory basics in drug and medical device manufacturing to risk management in the production process. "Specifically, our project focuses on wound healing and the development of innovative medical products," Oliver Pullig reported, praising the warm hospitality of the Turkish colleagues.

Training sessions, lectures, trade fair visits, workshops, and much more

Four weeks later, there was a reunion in Würzburg. The guests first completed a three-day course at the Fraunhofer Translation Center on 3D testing systems, followed by two days of practical training at UKW. The highlight was a tour of the new cleanrooms at the Center for Internal Medicine (ZIM). Since these are nearing completion and not yet officially approved, an on-site briefing was possible.

"It is a really nice project that not only makes sense but is also enjoyable," says Oliver Pullig. The regular project meetings are complemented by online lectures on regenerative medicine and materials, joint trade fair and conference visits, special training programs for women in research, scientific writing, fundraising, and much more.