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

PDA Virus Conference 2024, Amsterdam, The Netherlands
June 14, 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.

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