Biotherapeutics Development with GMP-Compliant NGS Assays In-House

August 12, 2025

Biopharmaceutical companies are increasingly adopting next-generation sequencing (NGS)-based assays to assess Critical Quality Attributes (CQA) and ensure the safety of biotherapeutics. The foundation for producing monoclonal antibodies, recombinant proteins, gene and cell therapies, and vaccines, cell lines, and drug products must be rigorously characterized to meet stringent quality standards. As the need for standardized testing grows and the volume of samples increases, organizations make a strategic decision to establish in-house NGS workflows. This offers significant advantages that range from enhanced data protection to reduced costs. However, for this to succeed, validated in-house platforms are required. Successful validation demands careful consideration of variability in methods, instruments and protocol standardization, robust data handling, and adherence to regulatory compliance. Genedata Selector^® is an innovative enterprise software platform designed to address these challenges while meeting GMP requirements. It creates a single source of truth for all NGS data across analytical development and manufacturing activities. The platform includes GMP-compliant features and enables a multi-attribute method (MAM) approach for NGS, successfully replacing outsourcing services. With this, biopharmaceutical companies can streamline the in-house analysis of NGS assays, ensuring greater scalability, faster turnaround times, and higher ROI for product development and manufacturing.