Dr. rer. nat. Nicole Kühl

Co-founder, cell and molecular biologist, and GMP and QA expert, ANOVA Institute for Regenerative Medicine

Nicole Kühl is a cell and molecular biologist, GMP expert and co-founder of ANOVA. Her career has been shaped by one central question: how can biological processes, which are inherently variable, be translated into reproducible, safe and regulatorily robust therapies?

She studied biology at the Technical University of Karlsruhe and the University of Bremen, specialising in neurobiology and molecular cell biology. In her doctoral thesis, completed magna cum laude, she investigated how heat stress affects the proliferation and cell-cycle control of glioma cells. This work led to several scientific publications on cell-cycle regulation, cellular stress responses and thermotolerance.

She then moved to the University Medical Center Groningen in the Netherlands. There she worked on therapy-oriented research projects on multiple sclerosis, investigating how growth factors and their binding proteins influence the survival and differentiation of oligodendrocytes. The focus was on primary oligodendrocytes, astrocytes and microglia – the cell types whose interplay is decisive for the maintenance and regeneration of the myelin sheaths in the central nervous system.

She continued this research at Jacobs University Bremen, first as a researcher and later as a group leader and lecturer in biochemistry and cell biology. Her scientific work encompassed primary human and animal cell cultures, mesenchymal stromal cells, numerous established cell lines, cell viability and proliferation assays, apoptosis and cell-cycle analyses, flow cytometry, fluorescence and laser-scanning microscopy, as well as molecular-biological and protein-biochemical methods.

Working with complex biological systems led early on to a second focus: the question of how cell-culture procedures can be standardised without losing sight of the cells' biological properties. From 2008 to 2011, Kühl headed the PromoCell Academy, where she developed scientific and practical training concepts for cell culture and quality management.

At the request of the German Institute for Standardization (DIN), Dr. Kühl was a member of the working group "Incubators for Tissue Engineering" in 2011 and 2012. In this role she contributed her scientific and practical expertise in cell culture and in the cultivation of sensitive primary cells to the standardisation work, and gave a specialist lecture on GMP requirements in the DIN working group.

In 2012 she founded InCelligence, a training and consulting platform for cell culture, quality management and GMP. Since then she has delivered more than 100 in-house training courses as well as numerous open specialist courses for pharmaceutical and biotechnology companies, production laboratories, quality-control departments and research institutions. Her courses combine theory and hands-on laboratory work and cover in particular cell culture under GMP, GMP requirements for ATMPs, aseptic working techniques, contamination control, cell banks, cryopreservation, and the development, optimisation and validation of cell-based bioassays.

Together with Michael Stehling she founded the ANOVA Institute for Regenerative Medicine in 2016. There she took on a leading external role in quality assurance and established the quality-related and regulatory foundations for the GMP-compliant manufacture of novel cell products.

Kühl led the quality and regulatory preparation of a manufacturing authorisation under Section 13 of the German Medicinal Products Act (AMG) as well as the authorisations under Sections 20b and 20c AMG. These authorisations created the manufacturing basis for bone marrow concentrate (BMC) and a secretome product derived from mesenchymal stromal cells. One of these projects led to an approved first-in-human application in 2018. This established at ANOVA the regulatory and production basis for translational treatments using scientifically defined cell products manufactured under controlled conditions.

Her role at ANOVA extends beyond the formal implementation of regulatory requirements. She connects the biological properties of cells and cell products with the requirements of manufacturing, quality control, documentation, method validation and reproducible processes. This combination of experimental cell biology, GMP experience and quality assurance forms an essential basis for the development and controlled manufacture of the regenerative medicinal products used at ANOVA.