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AI-Driven, GMP-Compliant Digital Infrastructure for NGS-Based Decision-Making in Development and Manufacturing

May 26, 2026

Biopharmaceutical manufacturing increasingly relies on advanced analytics to ensure the quality, safety, and consistency of cell lines. While next-generation sequencing (NGS) provides critical insights into genetic identity, integrity, and safety, its broader adoption across R&D and manufacturing remains constrained by fragmented workflows and limited interoperability. Genedata Selector® addressed this challenge, by streamlining NGS assay development and execution in GMP-compliant environments, while integrating multi-omics and bioprocess data and establishing a FAIR-compliant foundation for AI-driven analytics. 

Genedata Selector seamlessly connects sequencing instruments with ELN, LIMS platforms, bioprocess information to automate high-throughput workflows, standardize assay design, and enable audit-ready reporting with embedded quality checkpoints. By consolidating metadata, raw and processed sequencing data, and metabolomics and proteomics datasets, within a unified ecosystem, we establish an AI/ML-ready data layer that supports predictive modeling. This digital infrastructure bridges the gap between cell-based products research and manufacturing, optimizing development timelines and scalability, while reducing risk from discovery to commercial production.

 


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