403
Sorry!!
Error! We're sorry, but the page you were looking for doesn't exist.
Clean Cells launches Next-Generation Sequencing (NGS) offering for viral safety testing
(MENAFN- ALA Group) Expanded NGS offering now covers GMP-compliant viral safety testing for viral vectors and recombinant preparations, building on existing identity testing capabilities
Acquisition of bioinformatics CRO Xegen secures bioinformatics capacities and provides backbone of comprehensive NGS capabilities from sample preparation to data interpretation
Single-partner offering gives gene therapy, vaccine, mRNA and recombinant product developers end-to-end traceability across wet-lab testing, sequencing and bioinformatics
Montaigu Vendée near Nantes, France, September 8, 2026 - Clean Cells, a leading biopharmaceutical quality control services provider specializing in biologics GMP testing and a subsidiary of the Clean Biologics Group, today announces the launch of its Next-Generation Sequencing (NGS)-based safety testing for viral matrices, such as viral vectors and recombinant preparations, building on its already-established NGS offering for identity testing.
Simultaneously, Clean Cells acquired French bioinformatics CRO Xegen, which specializes in NGS data analysis. This will help consolidate, develop and secure Clean Cells’ bioinformatics capabilities to support every NGS method and de-risk the most technically complex part of the workflow. A secured bioinformatics backbone, the most critical part of NGS, means reliable, auditable data handling. Financial details were not disclosed.
Clean Cells has acquired Xegen’s IP, software, pipelines and facilities at Gemenos near Marseille, France. Xegen co-founder and CEO, Dr Julien Paganini, will join Clean Cells as Expert Project Manager Bioinformatics, Analytical Methods Development and Validation, along with his team of two staff.
“Our clients do not buy a technique; they buy confidence in their product. With the launch of our NGS viral safety testing and the acquisition of Xegen’s Next-Generation Sequencing bioinformatics expertise, we provide a strong and secure analytical pipeline, with greater control of the full workflow from sample to interpreted result. We can provide our international clients with a more integrated NGS offering to support key questions from identity to viral safety,” said Laurent Claisse, CEO of Clean Cells. “We will continue driving our growth strategy by reinforcing the core capabilities of our operations.”
“Sequencing is the technology but turning it into a quality control solution involves much more than simply generating reads. It requires a robust analytical strategy to transform complex data into interpretable, traceable and regulatory-ready results. By joining Clean Cells, we can combine our established bioinformatics structure and deep expertise with its laboratory and regulatory capabilities to build a fully integrated solution and make NGS a powerful and practical tool for quality control in regulated environments,” added Dr. Julien Paganini, co-founder and CEO of Xegen.
This new offering comes at a critical time, as European regulatory frameworks are making NGS increasingly relevant in checking that biologic medicines are not contaminated with unwanted viruses. Clean Cells’ strategic move strengthens its position in the viral safety testing market in step with European regulations, notably ICH Q5A(R2) (2024) and European Pharmacopoeia chapter 2.6.41, which are accelerating NGS adoption from a niche technology to a mainstream viral safety testing tool.
"The regulatory ground has shifted. With ICH Q5A(R2) and European Pharmacopoeia chapter 2.6.41, NGS is now a recognized route for adventitious virus detection; it answers a real problem for viral matrices, where classical assays struggle because no anti-serum exists. The sequencing alone is not the whole story; a signal still must be investigated and confirmed, and that is where having the full quality control panel alongside it makes a difference,” explained Elodie Ribert, R&D deputy director, head of Analytical Development and Validation at Clean Cells.
Gene therapy, vaccine, mRNA and recombinant product developers can now benefit from Clean Cells’ single partner capabilities. These span wet-lab testing, sequencing and bioinformatics, enabling improved data continuity across workflows, end-to-end traceability, confidence in genomic results and a more integrated path to regulatory submission.
Going forward, Clean Cells will extend the validated NGS viral safety method from acellular viral matrices to cell banks (MCB/WCB); this is currently in progress. It will also build additional viral safety expert capacity and business development enablement.
About Xegen
Xegen is a bioinformatics and software development company specialized in NGS and molecular biology data analysis, interpretation and workflow management. Xegen supports its customers and partners in defining analytical strategies, processing and interpreting complex biological data, and developing automated, high-value software solutions for regulated life sciences environments.
Xegen develops PolyPhemeDiag, a modular platform dedicated to NGS and PCR data analysis and interpretation, as well as analytical workflow management.
Acquisition of bioinformatics CRO Xegen secures bioinformatics capacities and provides backbone of comprehensive NGS capabilities from sample preparation to data interpretation
Single-partner offering gives gene therapy, vaccine, mRNA and recombinant product developers end-to-end traceability across wet-lab testing, sequencing and bioinformatics
Montaigu Vendée near Nantes, France, September 8, 2026 - Clean Cells, a leading biopharmaceutical quality control services provider specializing in biologics GMP testing and a subsidiary of the Clean Biologics Group, today announces the launch of its Next-Generation Sequencing (NGS)-based safety testing for viral matrices, such as viral vectors and recombinant preparations, building on its already-established NGS offering for identity testing.
Simultaneously, Clean Cells acquired French bioinformatics CRO Xegen, which specializes in NGS data analysis. This will help consolidate, develop and secure Clean Cells’ bioinformatics capabilities to support every NGS method and de-risk the most technically complex part of the workflow. A secured bioinformatics backbone, the most critical part of NGS, means reliable, auditable data handling. Financial details were not disclosed.
Clean Cells has acquired Xegen’s IP, software, pipelines and facilities at Gemenos near Marseille, France. Xegen co-founder and CEO, Dr Julien Paganini, will join Clean Cells as Expert Project Manager Bioinformatics, Analytical Methods Development and Validation, along with his team of two staff.
“Our clients do not buy a technique; they buy confidence in their product. With the launch of our NGS viral safety testing and the acquisition of Xegen’s Next-Generation Sequencing bioinformatics expertise, we provide a strong and secure analytical pipeline, with greater control of the full workflow from sample to interpreted result. We can provide our international clients with a more integrated NGS offering to support key questions from identity to viral safety,” said Laurent Claisse, CEO of Clean Cells. “We will continue driving our growth strategy by reinforcing the core capabilities of our operations.”
“Sequencing is the technology but turning it into a quality control solution involves much more than simply generating reads. It requires a robust analytical strategy to transform complex data into interpretable, traceable and regulatory-ready results. By joining Clean Cells, we can combine our established bioinformatics structure and deep expertise with its laboratory and regulatory capabilities to build a fully integrated solution and make NGS a powerful and practical tool for quality control in regulated environments,” added Dr. Julien Paganini, co-founder and CEO of Xegen.
This new offering comes at a critical time, as European regulatory frameworks are making NGS increasingly relevant in checking that biologic medicines are not contaminated with unwanted viruses. Clean Cells’ strategic move strengthens its position in the viral safety testing market in step with European regulations, notably ICH Q5A(R2) (2024) and European Pharmacopoeia chapter 2.6.41, which are accelerating NGS adoption from a niche technology to a mainstream viral safety testing tool.
"The regulatory ground has shifted. With ICH Q5A(R2) and European Pharmacopoeia chapter 2.6.41, NGS is now a recognized route for adventitious virus detection; it answers a real problem for viral matrices, where classical assays struggle because no anti-serum exists. The sequencing alone is not the whole story; a signal still must be investigated and confirmed, and that is where having the full quality control panel alongside it makes a difference,” explained Elodie Ribert, R&D deputy director, head of Analytical Development and Validation at Clean Cells.
Gene therapy, vaccine, mRNA and recombinant product developers can now benefit from Clean Cells’ single partner capabilities. These span wet-lab testing, sequencing and bioinformatics, enabling improved data continuity across workflows, end-to-end traceability, confidence in genomic results and a more integrated path to regulatory submission.
Going forward, Clean Cells will extend the validated NGS viral safety method from acellular viral matrices to cell banks (MCB/WCB); this is currently in progress. It will also build additional viral safety expert capacity and business development enablement.
About Xegen
Xegen is a bioinformatics and software development company specialized in NGS and molecular biology data analysis, interpretation and workflow management. Xegen supports its customers and partners in defining analytical strategies, processing and interpreting complex biological data, and developing automated, high-value software solutions for regulated life sciences environments.
Xegen develops PolyPhemeDiag, a modular platform dedicated to NGS and PCR data analysis and interpretation, as well as analytical workflow management.
Legal Disclaimer:
MENAFN provides the
information “as is” without warranty of any kind. We do not accept any
responsibility or liability for the accuracy, content, images, videos,
licenses, completeness, legality, or reliability of the information
contained in this article. If you have any complaints or copyright issues
related to this article, kindly contact the provider above.
Comments
No comment