Reliable G-CSF and GM-CSF Potency Testing Using assay ready instaCELLs

Reliable G-CSF and GM-CSF Potency Testing Using assay ready instaCELLs

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Presented by: Oliver Wehmeier, acCELLerate Poster Session: The Weird and The Wonderful Thursday, 25 Sept. at 15:45 ----- Granulocyte colony-stimulating factor (G-CSF) and granulocyte-macrophage colony-stimulating factor (GM-CSF) are key cytokines regulating the formation and function of immune cells. Their recombinant forms, Filgrastim (G-CSF) and Sargramostim (GM-CSF), are used therapeutically, for example to support bone marrow regeneration following chemotherapy or transplantation. Precise proliferation bioassays are essential for quality control of these biopharmaceuticals. Conventionally, such assays require labor-intensive cell culture and serum starvation to arrest cells in a quiescent state. In this study, we evaluated the use of assay-ready instaCELLs, which are cryopreserved and can be applied immediately after thawing without further preparation. Using TF-1 cells to assess GM-CSF potency and NFS-60 cells for G-CSF potency, we demonstrated that starvation is no longer required by using instaCELLs. During cryopreservation the cells already get into a quiescent, non-dividing state. Assay-ready instaCELLs yielded highly precise, reproducible, and consistent dose-response curves equivalent to those obtained with conventionally starved cells. Our results show that instaCELLs provide a robust, standardized, and time-saving approach for cytokine potency testing. By eliminating variability from cell culture, passage, and starvation, assay precision and reliability are significantly improved. instaCELL-based bioassays are therefore ideally suited for research and industrial quality control applications. Contributing Authors: Johannes Peteler¹, Yannick Prange1 Karen Hinsch¹, Oliver Wehmeier¹ ¹ acCELLerate GmbH, Hamburg, Germany

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https://bebpa.org/posters/2025/EUB/acCELLerate.pdf
acCELLerateacCELLerate is a specialist for large-scale production and cryopreservation of highly functional assay-ready cells. The instant use of cells from a frozen stock became a widely accepted approach preferred to continuously passaged cells. Assay-ready cells are used manifold for the screening of new drugs, the animal-free safety testing, and for the potency testing of biotherapeutics in clinical development and manufacturing control. Assay-ready cells increase the flexibility of any cell-based project and can significantly improve assay precision. Based on 16 years of experience, acCELLerate has developed freezing protocols and established well-controlled processes to prepare assay-ready Frozen Instant Cells of high quality and robustness. Frozen Instant Cells can be used like a reagent without prior cultivation. acCELLerate provides assay-ready cells from multiple cell lines, validated instaCELL bioassay kits, as well as custom cell banks of Frozen Instant Cells with comprehensive documentation to meet specific requirements of the different fields of application.