AI-generated from publicly available materials.Clean Cells has expanded its viral safety testing capabilities by launching a next-generation sequencing (NGS) service, aimed at enhancing the analysis of viral vectors and recombinant preparations. This initiative is bolstered by the acquisition of Xegen, a bioinformatics CRO specializing in NGS data analysis.
The integration of Xegen is intended to fortify Clean Cells' bioinformatics infrastructure, which is crucial for ensuring reliable and auditable data management in NGS workflows. CEO Laurent Claisse emphasized that a robust bioinformatics framework is essential for handling complex data effectively, thereby reducing risks associated with technical challenges. Xegen's co-founder, Julien Paganini, will lead the bioinformatics projects at Clean Cells, bringing his expertise and team to enhance analytical methods and validation processes.
This development is particularly timely, as European regulatory standards are increasingly recognizing NGS as a vital tool for ensuring the safety of biologic medicines against viral contamination. Clean Cells aims to position itself advantageously in the evolving landscape of viral safety testing, aligning with upcoming regulations such as ICH Q5A(R2) and European Pharmacopoeia chapter 2.6.41, which advocate for NGS adoption in routine testing.
Looking ahead, Clean Cells plans to extend its validated NGS methods to include cell banks, reflecting a commitment to advancing its viral safety testing offerings. This strategic move not only enhances their service portfolio but also addresses critical needs in the industry, as traditional assays often fall short in detecting certain viral contaminants.