Clean Cells Broadens Viral Safety Testing Portfolio with NGS
The expanded next-generation sequencing offering from Clean Cells now covers GMP-compliant viral safety testing for viral vectors and recombinant preparations, building on existing identity testing capabilities. The post Clean Cells Broadens Viral Safety Testing Portfolio with NGS appeared first on GEN - Genetic Engineering and Biotechnology News .
Clean Cells, a France-based company, has expanded its viral safety testing portfolio by launching next-generation sequencing (NGS)-based safety testing for viral matrices, including viral vectors and recombinant preparations. The company has also acquired Xegen, a French bioinformatics contract research organization (CRO), to bolster its bioinformatics capabilities and streamline its workflow.
Clean Cells' CEO, Laurent Claisse, highlighted that the acquisition will help consolidate, develop, and secure the company's bioinformatics capabilities, ensuring reliable and auditable data handling.
Julien Paganini, co-founder and CEO of Xegen, will join Clean Cells as an expert project manager for bioinformatics, analytical methods development, and validation. Together with his team of two staff members, Paganini will help build a fully integrated solution that combines Clean Cells' laboratory and regulatory capabilities with Xegen's established bioinformatics structure and deep expertise.
This strategic move comes at a crucial time as European regulatory frameworks, such as ICH Q5A(R2) (2024) and European Pharmacopoeia chapter 2.6.41, are making NGS increasingly relevant for checking biologic medicines' contamination with unwanted viruses.
Elodie Ribert, R&D deputy director, head of analytical development and validation, emphasized that NGS is now a recognized route for adventitious virus detection, providing a reliable solution for viral matrices, where classical assays struggle due to the lack of anti-serums. Clean Cells plans to extend its validated NGS viral safety method to cell banks (MCB/WCB) and build additional viral safety expert capacity to support the growing demand for NGS in regulatory environments.
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