Minaris has introduced the AgentSCREEN, a next-generation sequencing (NGS) platform that aims to enhance the detection of adventitious viruses in biologics and advanced therapy products. This GMP-qualified platform is designed to streamline viral safety testing for pharmaceutical and biotechnology companies, particularly those involved in developing monoclonal antibodies, vaccines, and cell and gene therapies.
The AgentSCREEN assay employs a transcriptomic NGS approach, analyzing all messenger RNA (mRNA) in a cell bank sample to identify viral RNA transcripts. This innovative method is capable of detecting active viral infections from both RNA and DNA viruses. The sequencing data generated are processed through a custom bioinformatics pipeline, validated according to GAMP 5 standards, which compares the results with the Reference Viral Database (RVDB) curated by the FDA’s Center for Biologics Evaluation and Research (CBER).
Minaris reports that the platform offers a predictable turnaround time of 28 days, thereby simplifying the complexities associated with viral safety testing strategies. The AgentSCREEN system allows for broad detection of known and unknown virus species across various viral taxa and genome types. It is intended to complement traditional in vitro cell culture assays, forming part of a comprehensive adventitious agent testing strategy.
Streamlining Viral Safety Testing
According to Heather Malicki, Head of Analytical Sciences at Minaris, “NGS results are only useful when teams can translate them into action. With AgentSCREEN, sponsors get direct access to virology expertise throughout execution and follow-up, so they can move from detection to risk assessment and response planning more efficiently.”
Minaris has developed the AgentSCREEN platform in response to evolving regulatory guidance that encourages the adoption of NGS methods to support viral safety strategies. The platform will be officially introduced to industry stakeholders at the Festival of Biologics USA in San Diego, where Minaris will showcase its capabilities and applications in viral detection testing.
As the biopharmaceutical industry continues to advance, tools like AgentSCREEN are critical for ensuring the safety and efficacy of emerging therapies. By integrating cutting-edge technology with regulatory compliance, Minaris is positioning itself as a leader in the field of viral safety testing.
