Charles River and PathoQuest Publish Study Validating Proprietary Next-Generation Sequencing Viral Safety Assay
The results showed that PathoQuest’s proprietary NGS approach is an effective, more robust replacement to in vivo adventitious virus testing of cell substrates used in the production of biologics, like monoclonal antibodies, vaccines, cell, and gene therapies.
On Sept. 6, 2023, Charles River Laboratories International and PathoQuest announced the publication of the results of a seminal study in Vaccine, which demonstrated the proprietary, good manufacturing practice (GMP) grade, next-generation sequencing (NGS)-based assay from PathoQuest had a greater capability of detecting viral contaminants when compared to in vivo assays.
The objective of the study was to compare classical in vivo testing methods used to screen cell lines for adventitious viruses with a GMP-compliant viral transcriptome NGS assay. Further, the study was conducted as a head-to-head comparison of standard in vivo testing and NGS-based testing of cell substrates.
According to the press release, the team of Charles River experts prepared test materials and ran the in vivo assays, while PathoQuest’s team tested the material with their proprietary NGS-based assay. There were cells infected with a wide variety of viruses reflective of the diversity and various patterns of virus-cell interactions in a real-world setting for biologics to determine the range of detection. Additionally, the infected cells were increasingly mixed with uninfected cells to further assess the analytical sensitivity and analyzed across several conventional in vivo tests and with the NGS-based transcriptomic assay.
The results showed that PathoQuest’s proprietary NGS approach is an effective, more robust replacement to in vivo adventitious virus testing of cell substrates used in the production of biologics, like monoclonal antibodies, vaccines, cell, and gene therapies.
“Our study demonstrates that PathoQuest’s unique NGS assay significantly increases the capability of detecting viral contaminations in cell substrates like cell banks, the starting material for biologics production, and in bioreactors during biologics production. The test has been validated to GMP standards and provides the pharmaceutical industry a faster, more efficient, and reliable testing option compared to animal-based testing,” said Professor Marc Eloit, DVM, PhD, head of the Pathogen Discovery Laboratory at the Institute Pasteur and Founder of PathoQuest, in a press release.
Source: Charles River
