Colette Cote from PathoQuest presented at the Biopharma Day at the Nanopore Community Meeting in Boston. The session’s title was “The art of GMP in the world of NGS: trials, tribulations and a whole lot of acronyms—a success story.” The speakers discussed GMP compliance and the history of next-generation sequencing. Cote explained that there is guidance that must be followed. Tests can be qualitative or quantitative, and accuracy, linearity, range, precision, robustness, specificity, and limit of detection are considered! Numerous regulations may (or may not) apply. Data integrity is also guided by regulation. Tests and equipment need to be validated. Cote shared that the integration site assay is the first Oxford Nanopore-driven GMP-compliant biosafety testing assay for the characterization of engineered cell lines, including CHO cells. They performed concurrent, harmonized validation at two different sites, four sequencers (GridION), four operators, and lots of ancillary equipment and harmonized logistics. The goal is to achieve a GMP-compliant test. Cote shared stories and examples and emphasized that it can be done!
