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Minaris Advances Viral Safety Testing with AgentSCREEN

In a groundbreaking move for the biopharmaceutical industry, Minaris, a prominent player in the field of cell and gene therapy, has introduced its latest innovation: the AgentSCREEN Adventitious Virus Detection platform powered by Next Generation Sequencing (NGS). This state-of-the-art system is designed to significantly enhance viral safety testing processes for cell banks and cell-based samples, a vital aspect of developing both traditional biologics and advanced therapies.

Launched on March 4, 2026, AgentSCREEN operates under Good Manufacturing Practice (GMP) standards, aiming for a streamlined approach to identifying potential viral contaminants within biologics. Minaris specializes in offering comprehensive biosafety testing, and this novel platform addresses growing demands from biopharma innovators who require reliable and efficient testing methods.

The Advanced Technology Behind AgentSCREEN

The AgentSCREEN platform utilizes a transcriptomic NGS technique, ensuring a quick 28-day turnaround for results. It meticulously analyzes all messenger RNA present in a cell bank sample to detect any viral RNA transcripts, providing an effective means to identify active viral infections, whether they stem from RNA or DNA viruses. A custom bioinformatics pipeline, validated using GAMP 5 standards, enables precise comparisons of the sequencing data against the extensively curated Reference Viral Database (RVDB) established by CBER and the FDA. This ensures accurate identification of any viral contaminants, which is essential for maintaining product integrity.

Heather Malicki, Head of Analytical Sciences at Minaris, emphasized the importance of actionable results, stating, “NGS results are only useful when teams can translate them into action.” With AgentSCREEN, sponsors gain direct access to virology expertise throughout the execution of tests and subsequent data interpretation, facilitating a more efficient transition from detection to risk assessment and response planning.

Streamlining Compliance and Testing

Recent regulatory guidelines, particularly ICH Q5A(R2), have begun advocating for the integration of NGS methodologies into viral safety strategies as an alternative to traditional in vivo testing methods. This shift reflects the growing recognition of NGS’s potential to deliver enhanced sensitivity and reduce overall testing durations. AgentSCREEN has been purposefully designed to align with these regulatory advancements, providing a robust framework supported by defined performance characteristics and interpretation pathways that help sponsors adopt an NGS-based strategy within a GMP framework.

Minaris’s AgentSCREEN offering simplifies viral safety testing by delivering:

• - Comprehensive detection capabilities for unknown or unexpected viral species across different viral taxa and genomic types.
• - Complementary support for in vitro cell culture assays, adding a valuable layer to overall adventitious agent testing protocols.
• - Consistent 28-day turnaround times for efficient reporting.
• - Centralized testing and follow-up operations conducted at a single U.S. site.
• - Direct consultation with virology experts throughout both the execution and interpretation processes.
• - Contributions to global initiatives aimed at reducing reliance on animal testing, by providing alternatives to in vivo methods as appropriate.

The development of AgentSCREEN is the result of collaboration with industry experts and active participation in studies such as the National Institute for Biological Standards and Control (NIBSC), which focused on evaluating reference materials for adventitious agent detection through deep sequencing methods.

Minaris’s Commitment to Quality

Minaris has been developing the AgentSCREEN platform since 2012 and has successfully utilized it in research and development with major stakeholders in the industry, including working with FDA scientists. The workflow has proven capable of detecting all 25 viruses outlined in NIBSC's evaluation, demonstrating its reliability and sensitivity. Performed on Ion Torrent sequencing systems, the platform is supported by software environments that comply with Part 11 regulations, which are critical for maintaining data integrity and compliance within GMP testing parameters.

Dr. Luciana Mansolelli, Minaris’s Chief Quality Officer, notes, “Quality and traceability are foundational to GMP testing, especially for comprehensive detection methods like NGS.” The GMP qualification for AgentSCREEN underscores Minaris's dedication to maintaining stringent controls, acceptance criteria, and documentation practices necessary for accurate interpretation and program-ready reporting.

The formal introduction of the AgentSCREEN platform will occur during the upcoming Festival of Biologics USA in San Diego. Keynote address by Christine Mitchell, Senior Scientific Fellow at Minaris Advanced Testing, will delve into the AgentSCREEN process as a potential substitute for traditional in vivo evaluations—a pivotal discussion in today's evolving therapeutic landscape.

In conclusion, Minaris is fostering advancements in viral safety testing through the AgentSCREEN platform, exemplifying its commitment to innovation and quality assurance within the realm of cell and gene therapies. By providing a comprehensive, efficient solution for viral safety assessments, Minaris is indeed paving the way for increased safety and reliability in biopharmaceuticals.

For more information on AgentSCREEN and Minaris Advanced Testing, please visit Minaris.com.