We See a Way to
reduce CLD project times by 50% using NGS
Genedata | Genedata Selector
Characterize Cell Lines with a Data-Driven Approach
Automating Critical Quality Attribute (CQA) Analysis
One significant challenge in cell line development is the efficient and accurate analysis of complex NGS data for quality control. Genedata Selector addresses this by automating NGS data analysis using customizable Playbooks. These wizard-based guides implement NGS as a multi-attribute method (MAM), generating multiple QC readouts from a single assay, reducing time and costs. The Playbooks analyze both short-read and long-read NGS data to evaluate attributes such as clone identity, integration sites, gene integrity, and the detection of adventitious agents — all in a single run. Regular testing of CQAs ensures cell lines remain free from contaminants and genetically stable, streamlining the QC process.
Regulatory Compliance, Validation, and Reporting
Within a single, scalable platform, Genedata Selector streamlines the in-house validation of NGS assays and GMP-compliant reporting. It efficiently handles multiple assays, supports regulatory submissions, and consolidates all necessary data in one place. This allows companies to focus on their core objectives without the burden of developing and maintaining an NGS infrastructure or lengthy validation processes. The result is more efficient and compliant biopharmaceutical production.
Resources
Webinar
Facilitating the Journey to Validated In-House NGS Workflows
In this webinar, Ludwig Macko, Head of Selector Development at Genedata, shares practical insights from real-world experiences on how to successfully validate in-house NGS workflows. He outlines a strategic, step-by-step approach tailored to the unique needs of biopharma organizations, ranging from configuring lab instruments to establishing robust, compliant methods.
Application Note
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.