Achieving GMP Compliance and Efficiency in NGS Data Processing

February 25, 2025

Biopharmaceutical companies are increasingly adopting next-generation sequencing (NGS)-based assays to assess Critical Quality Attributes (CQA) to ensure the safety of biotherapeutics. Regulatory authorities often request detailed CQA information during the Investigational New Drug (IND) application process. However, NGS-based assays present substantial computational challenges in processing, analyzing, and managing NGS data. Genedata Selector^® addresses these challenges by providing a single source of truth for all NGS data, streamlining workflows, and enabling biopharmaceutical companies to keep the entire process in-house. With 21 CFR Part 11 compliant and in a validation-ready documentation package, Genedata Selector simplifies testing, adheres to ICH Q5A(R2) guidelines, and ensures improved return on investment by providing reliable results and faster turnaround time.