04.22.26 -- Technological advances in biosafety testing which will de-risk and reduce your regulatory timelines

Gain insight into a modern sequencing‑based assay that strengthens cell line characterization with greater sensitivity. Learn more about how it supports confident, objective safety decisions and helps reduce risk during early development.

ICH Q5A(R2) is explicit: Molecular methods such as NGS should replace in vivo testing for cell banks when validated, with supporting investigation strategies. The 3Rs framework (Reduce, Refine, Replace) is no longer just ethical guidance; it is now referenced directly in the regulatory expectation for biosafety strategy design. 

Blazar® tNGS Rodent Virus Panel is the next generation assay for rodent cell bank characterization. It delivers species-specific viral detection in just 13 days using targeted NGS, replacing MAP/HAP tests. With proven robustness across hundreds of cell banks, the panel has been used to support successful regulatory submissions.