Biocompatibility Studies On CHO Cell Culture In X-ray Irradiated BioBLU® Single-Use Bioreactors

By Nathalie Chandelier, Muriel Art, Pascal Rowart, Françoise de Longueville

In cell culture, the leakage of toxic or inhibitory chemicals from single-use bioreactors has become a growing concern. These leachables can migrate from plastic components into the culture medium, potentially disrupting cell growth and compromising product quality. With the recent shift to X-ray irradiation for vessel sterilization, an updated study was necessary to ensure safety using the standardized cell-based assay from the DECHEMA^® Society for Chemical Engineering and Biotechnology. This updated assessment utilized a genetically modified CHO cell line to evaluate and compare the impact of different plastic materials. Following the "DECHEMA Recommendation for Leachables Studies," the latest study confirms that X-ray irradiated materials pose no adverse effects on cell growth, viability, or metabolic activity, ensuring their safety in mammalian cell cultures.