Minaris Launches AgentSCREEN Adventitious Virus Detection By NGS To Simplify Viral Safety Testing For Cell Banks And Cell-Based Samples

GMP-qualified NGS adventitious virus detection with a predictable 28-day turnaround and U.S.-based end-to-end support

PHILADELPHIA, PA — Minaris, a global cell and gene therapy (CGT) contract development and manufacturing organization (CDMO) and multimodality biosafety testing provider, today announced the launch of AgentSCREEN Adventitious Virus Detection by Next Generation Sequencing (NGS). The GMP-qualified platform is designed to streamline adventitious agent testing for biopharma innovators developing traditional biologics such as monoclonal antibodies and vaccines, as well as advanced therapies including cell and gene therapies.

AgentSCREEN is a transcriptomic NGS approach with a predictable 28-day turnaround time. The assay examines all messenger RNA (mRNA) in a cell bank sample for the presence of viral RNA transcripts and is designed to detect active viral infections from RNA and DNA viruses. A custom GAMP 5 validated bioinformatics pipeline compares sequencing data to the Reference Viral Database (RVDB) curated by CBER/FDA to accurately identify viral contaminants.

”NGS results are only useful when teams can translate them into action,” said Heather Malicki, Head of Analytical Sciences at Minaris. “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.”

Recent regulatory guidance, including ICH Q5A(R2), encourages the use of Next Generation Sequencing (NGS) to support viral safety strategies as an alternative to traditional in vivo tests, reflecting the potential for greater sensitivity and reduced testing time. AgentSCREEN was developed to help sponsors implement an NGS-based approach within a GMP framework, supported by defined performance characteristics and interpretation pathways.

The AgentSCREEN offering is designed to simplify viral safety testing by providing:

• Broad, agnostic detection for unknown or unexpected virus species across viral taxa and genome types
• Ability to complement in vitro cell culture assays as part of an overall adventitious agent testing strategy
• Predictable 28-day turnaround time
• One U.S. site for NGS testing and follow-up work
• Direct access to virology experts and consultation throughout execution and interpretation
• Alignment with the global initiative to reduce animal testing, supporting alternatives to in vivo methods where appropriate
• Developed through industry collaboration and regulatory engagement, including participation in a National Institute Biological Standards and Control (NIBSC) study to evaluate reference material for Adventitious Agent Detection by Deep Sequencing.

Minaris began developing AgentSCREEN in 2012 and has used the platform in R&D with major developers, including co-publication with industry and FDA scientists. The platform includes transcriptomic and DNA/RNA-specific workflows, with qualification work generating specificity and limit-of-detection data. In the NIBSC study, the workflow demonstrated sensitivity by detecting all 25 viruses included in the evaluation. AgentSCREEN is performed on Ion Torrent sequencing systems and supported by Part 11-ready software environments to help meet data integrity and compliance expectations for GMP testing.

“Quality and traceability are foundational to GMP testing, particularly for broad, agnostic detection methods like NGS,” said Dr. Luciana Mansolelli, Chief Quality Officer of Minaris. “Our GMP qualification for AgentSCREEN reflects a deliberate focus on controls, acceptance criteria, and documentation practices that enable reliable interpretation and program-ready reporting.”

Minaris will introduce the GMP offering at the Festival of Biologics USA in San Diego. Christine Mitchell, Sr. Scientific Fellow, Minaris Advanced Testing, will present the AgentSCREEN approach in a keynote session titled “AgentSCREEN Adventitious Virus Detection by NGS as a Replacement for In Vivo Tests” on March 4.

About Minaris Advanced Testing

Minaris Advanced Testing provides multimodality biosafety testing services for cell and gene therapies and biologics, including viral clearance, biosafety testing, product characterization, and GMP analytics to support programs from development through commercial readiness. With a client-first approach, Minaris Advanced Testing delivers efficient, cost-effective testing solutions and a streamlined experience that makes it easier for sponsors to execute studies and advance their programs.

About Minaris

Minaris is a global cell and gene therapy (CGT) CDMO and multimodal biosafety testing organization. With more than 25 years of CGT development and manufacturing expertise and more than 40 years in biosafety testing, Minaris combines deep legacy experience with state-of-the-art GMP facilities as a fully U.S.-owned organization under new ownership and management, built for today’s evolving therapeutic landscape. Through its divisions, Minaris Advanced Therapies and Minaris Advanced Testing, the company supports innovators from IND through commercial supply and delivers GMP analytics, biosafety, viral clearance, and product characterization across CGT and biologics. With five global sites across three continents, Minaris is committed to helping partners bring more therapies to more patients worldwide. For more information, visit https://minaris.com or follow us on LinkedIn.