Replacing the Mouse, Hamster and Rat Antibody Production Tests (MAP, HAP, RAP) with Next Generation Sequencing iDTECT® Transcriptome assay

ICH Q5A(R2) is the key regulatory guidance document for the viral safety evaluation of cell lines used in the manufacture of biologics. This guideline now specifically references Next Generation Sequencing (NGS) as an advanced virus testing tool and an ethical replacement for virus assays in animal models. In collaboration with Charles River Laboratories, Pathoquest has generated data which underscores the superiority of their GMP validated iDTECT® Transcriptome assay over MAP/HAP/RAP in the characterization of rodent cell lines. This assay harnesses the power of NGS to screen cell lines for any replicating viral contaminants and allows the replacement of two mandatory animal-based assays: in vivo adventitious virus and MAP/HAP/RAP testing.