Genedata Selector: Next Generation Sequencing Based Biosafety Assessment of Biologics in a Validated Environment

May 10, 2024

Biopharmaceutical companies use Good Manufacturing Practice (GMP) guidelines to guarantee the safety of their biotherapeutic products. As a replacement for traditional assays, Next-Generation Sequencing (NGS) technology is becoming more prevalent in GMP settings. NGS plays a crucial role in preventing and identifying biological contamination throughout the manufacturing process, thereby ensuring product efficacy. Moreover, the ICHQ5A (R2) guideline advocates for the use of NGS as a substitute for animal testing. The Genedata Selector^® software streamlines the analysis of NGS-based data workflows, creating a single source of truth across various NGS instruments and assays. This software is equipped with functionalities required by GMP, and Genedata provides validation support services for CSV projects.