In biologics and cell and gene therapy, viral safety testing is both foundational and increasingly under pressure.
As advanced therapies move faster, pipelines grow more complex, and regulatory expectations evolve, sponsors are being asked to deliver broader viral detection, stronger data integrity, and reduced reliance on animal testing—without slowing development timelines. It is a tall order in a testing paradigm that has long relied on in vivo assays and cell culture systems developed decades ago.
Now, Minaris is positioning itself at the center of that shift.
The global cell and gene therapy CDMO and biosafety testing provider has launched AgentSCREEN™ Adventitious Virus Detection by Next Generation Sequencing (NGS), a GMP-qualified transcriptomic platform designed to simplify and modernize adventitious agent testing for both traditional biologics—such as monoclonal antibodies and vaccines—and advanced therapies.
More than a new assay, the move signals Minaris’ intent to operationalize NGS viral detection inside a GMP framework that sponsors can actually deploy at scale.
From Research Tool to GMP Platform
Next Generation Sequencing has long been discussed as the future of viral detection. Regulatory guidance, including ICH Q5A(R2), encourages the use of NGS to support viral safety strategies as an alternative to traditional in vivo tests, reflecting its potential for greater sensitivity and shorter timelines.
Yet despite years of technical validation across the industry, many sponsors have struggled to translate NGS from an exploratory R&D tool into a GMP-ready, regulatorily defensible solution.
Minaris began developing AgentSCREEN™ in 2012 and has used the platform in research settings with major developers, including co-publications with industry and U.S. Food and Drug Administration scientists, according to the company. The newly launched offering formalizes that work into a GMP-qualified service with defined performance characteristics, documentation controls, and interpretation pathways.
AgentSCREEN™ uses a transcriptomic NGS approach that examines all messenger RNA in a cell bank sample to detect viral RNA transcripts, allowing identification of active infections from both RNA and DNA viruses. Sequencing data are processed through a custom GAMP 5-validated bioinformatics pipeline and compared to the Reference Viral Database curated by FDA’s Center for Biologics Evaluation and Research (CBER).
The result, according to Minaris, is broad, agnostic detection across viral taxa with a predictable 28-day turnaround time—delivered through a single U.S. site with integrated follow-up support.
“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.”
Bridging Sensitivity and Compliance
The viral safety conversation is no longer just about detection limits. It is about regulatory defensibility, data integrity, and reproducibility under GMP conditions.
Minaris’ platform is performed on Ion Torrent sequencing systems and supported by Part 11-ready software environments to align with electronic records and compliance expectations. Qualification work generated specificity and limit-of-detection data, and in a National Institute for Biological Standards and Control (NIBSC) study evaluating reference material for Adventitious Agent Detection by Deep Sequencing, the workflow detected all 25 viruses included in the evaluation, according to the company.
That kind of validation matters in a landscape where sponsors must justify replacing or supplementing long-standing in vivo assays with newer molecular approaches.
“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.”
For cell and gene therapy developers in particular—where viral vectors, genetically modified cells, and complex raw materials increase both risk and scrutiny—the ability to pair broad detection with a defined interpretation framework could reduce ambiguity at critical regulatory milestones such as IND submissions or commercial readiness transitions.
An Industry at an Inflection Point
The timing is notable.
The industry is grappling with rising development costs, increased regulatory complexity, and mounting pressure to reduce animal testing where scientifically appropriate. Global initiatives to minimize in vivo assays have accelerated interest in molecular alternatives, but implementation has lagged behind enthusiasm.
AgentSCREEN™ is designed to complement traditional in vitro cell culture assays as part of a broader adventitious agent testing strategy, rather than serve as a standalone replacement in all cases. That positioning reflects the current regulatory reality: evolution, not overnight disruption.
Minaris will formally introduce the GMP offering at the Festival of Biologics USA in San Diego, where Christine Mitchell, Senior Scientific Fellow at Minaris Advanced Testing, is scheduled to present the approach in a keynote session titled “AgentSCREEN™ Adventitious Virus Detection by NGS as a Replacement for In Vivo Tests.”
The broader strategic play, however, extends beyond a conference debut.
With more than 25 years of cell and gene therapy development and manufacturing expertise and over 40 years in biosafety testing, Minaris is leveraging legacy experience to modernize one of the industry’s most entrenched quality functions. By embedding NGS-based detection within a compliant, consultative testing framework, the company is attempting to reduce friction between innovation and regulation.
Why It Matters for
For biologics and advanced therapy sponsors, viral safety testing is rarely the headline—but it is always the gatekeeper.
Delays in adventitious agent testing can stall clinical timelines. Ambiguous results can trigger costly investigations. Regulatory misalignment can push back approvals. As pipelines expand and modalities diversify, the need for broader, faster, and more interpretable viral detection is only intensifying.
If GMP-grade NGS platforms like AgentSCREEN™ can consistently deliver sensitivity, clarity, and compliance within predictable timelines, they may reshape how sponsors design viral safety strategies from the earliest stages of development.
In that sense, this launch is less about a single assay and more about a signal: viral safety testing is entering a new phase, where molecular breadth and regulatory rigor must coexist.
For Minaris, the bet is clear. The future of biosafety testing will not be defined solely by how many viruses can be detected—but by how confidently those findings can be translated into decisions that move therapies forward.
As advanced therapies continue to test the limits of traditional quality systems, the companies that can modernize those systems without compromising trust may define the next chapter of biomanufacturing readiness.
