Making NGS Work For Analytical Development And QC

By Justyna Lisowska, Genedata

This content is brought to you by Genedata, a Danaher Operating Company.

NGS can act as a single multi-attribute method, covering identity, sequence integrity, genetic stability, biosafety, and adventitious agent detection that would otherwise take several assays. Regulatory support is growing, including recognition of NGS in the revised ICH Q5A(R2). Yet sequencing capacity is only part of the picture. Analytical teams still contend with disconnected scripts, siloed data, and dependence on scarce bioinformatics expertise, all of which complicate standardization and transfer into QC and manufacturing. Consider how in-house analysis of short- and long-read data, built around step-by-step workflows called playbooks, addresses that gap and what GMP readiness demands from the start, from computerized system validation to audit trails and 21 CFR Part 11 compliance.

Explore the approach to see how flexible method design can lead to validation-ready execution.