Data-Driven NGS-Based Solutions for Cell Line Development & Characterization

The successful production of pharmaceuticals, including monoclonal antibodies, cell and gene therapy products, and vaccines, depends on the development and maintenance of safe, stable, and effective cell lines. Next-generation sequencing (NGS)-based workflows enable the comprehensive assessment of Critical Quality Attributes (CQAs) of cell lines, such as purity, stability, and identity. To fully harness the potential of NGS-based assays, a robust, end-to-end solution for data analysis, management, and reporting solution is essential.

Genedata Selector^® is an off-the-shelf digital analysis solution designed to streamline and optimize cell line development and characterization using NGS-based assays. The software automates complex NGS data analysis using Playbooks, pre-configured yet customizable analysis guides, and facilitates the implementation of NGS as a multi-attribute method (MAM), allowing users to generate multiple quality control (QC) readouts from a single assay. This eliminates the need for multiple assays, reducing time and costs. The platform seamlessly integrates into GMP-compliant environments and generates reports for internal documentation and regulatory submissions. With its ability to enhance efficiency and compliance, Genedata Selector is a game-changer for accelerating cell line development in the biopharmaceutical industry.