NGS as an Analytical Method for Regulatory-Compliant, Automated Monitoring of CQAs in Complex Biologics
May 26, 2026
Next-generation sequencing (NGS) enables monitoring of Critical Quality Attributes (CQAs) such as identity, integrity and purity/safety across modalities like cell and gene therapies, vaccines, and viral vectors. Regulators now recognize NGS for viral safety (ICH Q5A(R2)) and have adopted Ph. EUR 2.6.41 describing NGS method design and validation. We present Genedata Selector®, a validation-ready, digitalized framework automating NGS analytics, delivering traceable, compliance supporting reports, reducing analysis bottlenecks and accelerating decisions in development and CMC. Our approach combines sequencing-agnostic NGS-data analysis pipelines with automated step-by-step wizard-based guides to automate data processing, quality checks, result visualizations and go/no-go decision criteria for assessing CQAs including identity, integrity and purity. We provide 21 CFR part 11 features and CSV artifacts to operate NGS in GMP settings post validation. That significantly reduces error rates and shortens turnaround times. Standardized outputs can align with Process Analytical Technologies (PAT) for better process understanding.
Genedata Selector standardizes NGS analytics, reduces error risks, and unlocks insights into CQAs, from development through IND preparation. It unlocks automation for validated NGS assays, accelerating development, and supports robustness in the manufacturing of complex biologics. Standardized NGS-outputs, aligned with PAT systems, support GMP operations after successful validation, provide readouts for multiple CQAs, accelerate development, and enhance manufacturing robustness for complex biologics.
