- Minaris has launched AgentSCREEN™, a GMP-qualified next-generation sequencing (NGS) platform for detecting adventitious viruses in biologics and advanced therapy products.
- The platform offers broad viral detection with a 28-day turnaround time and is designed to support viral safety testing strategies for biologics, vaccines, and cell and gene therapies.
Minaris has launched AgentSCREEN™, a next-generation sequencing (NGS) platform designed to detect adventitious viruses in biologics and advanced therapy products. The GMP-qualified testing platform aims to support viral safety testing for pharmaceutical and biotechnology companies developing monoclonal antibodies, vaccines, and cell and gene therapies.
The AgentSCREEN™ assay uses a transcriptomic NGS approach that analyzes all messenger RNA (mRNA) present in a cell bank sample to identify viral RNA transcripts. The method is designed to detect active viral infections originating from both RNA and DNA viruses. Sequencing data are analyzed using a custom GAMP 5 validated bioinformatics pipeline that compares results with the Reference Viral Database (RVDB) curated by the FDA’s Center for Biologics Evaluation and Research (CBER).
According to the company, the platform delivers a predictable turnaround time of 28 days and is intended to simplify viral safety testing strategies. The system enables broad detection of known and unknown virus species across viral taxa and genome types and can complement traditional in vitro cell culture assays as part of a broader adventitious agent testing strategy.
“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.”
Heather Malicki, Head of Analytical Sciences at Minaris
Minaris stated that the platform was developed in alignment with evolving regulatory guidance encouraging the use of NGS methods to support viral safety strategies. AgentSCREEN™ will be introduced to the industry at the Festival of Biologics USA in San Diego, where the company will present the platform and its application in viral detection testing.
