Enhance Efficiency for Biopharmaceutical Manufacturing

Biopharmaceutical production depends on speed, consistency, and safety, spanning from early process development to commercial manufacturing. Genedata Selector brings next-generation sequencing (NGS) in-house with purpose-built workflows that support validated analytical assays across a wide range of drug modalities. By enabling real-time monitoring of critical quality attributes such as identity, purity, and stability, the platform ensures product compliance across all batches and sites. Its ability to centralize and standardize complex sequencing data supports faster decision-making and strengthens process control at every stage.

Automate Analytical Assays for Quality and Throughput

In both development and CMC (Chemistry, Manufacturing, and Controls) settings, rapid and accurate quality control (QC) is essential. Genedata Selector automates NGS-based analytical assays using guided Playbooks that deliver multiple QC readouts from a single run. Supporting both short- and long-read sequencing, the platform enables detection of contaminants, verification of sequence fidelity, and assessment of vector integration, all within a single, streamlined workflow. This reduces manual effort, shortens turnaround times, and ensures consistent results across production lines and development labs, ultimately leading to a significantly improved ROI.

Ensure Compliance with Scalable, Validated Workflows

Built for use in GMP-regulated environments, Genedata Selector simplifies the validation of NGS assays and supports audit-ready reporting. Its integrated platform consolidates all data, maintains full traceability, and facilitates regulatory submissions from early development through to commercial production. By eliminating the need for custom infrastructure and manual data handling, it allows teams to scale with confidence, accelerating the delivery of high-quality therapeutics.

Resources

Developing and Automating Gene Therapy Long-Read Based QC Assays

In this webinar, Andrew Hillhouse, Principal Scientist Group Lead at FUJIFILM Diosynth Biotechnologies, discusses the implementation of long-read next-generation sequencing (NGS) technology to develop automated Gene Therapy QC assays.

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