wave graphic mobile

AgentSCREEN™

AgentSCREEN™ GMP Adventitious Virus Detection by NGS

Minaris AgentSCREEN™ is a GMP-qualified Next Generation Sequencing (NGS) platform that simplifies adventitious agent testing with a predictable 28-day turn-around time, regulatory aligned workflow, and U.S. based end-to-end support.

NGS has been proven to provide the breadth, sensitivity and confidence needed for adventitious agent screening and is recognized as a key technology for biologic and advanced therapy providers striving to modernize their viral safety strategies and reduce their dependency on animal testing.

Connect With Our Experts

AgentSCREEN™ Benefits

Unbiased
Detection

Identifies expected and unexpected viral agents

Enhanced
Safety

Greater confidence in product viral safety

Broad
Coverage

Screens for multiple viral species in one assay

Lifecycle
Flexibility

Applicable from master to end of production cell bank

High
Sensitivity

Detects low-level viral contaminants

Regulatory
Alignment

Supports regulatory direction of reducing animal testing

Faster
Results

Shorter turn-around timelines than traditional virology assays

Rich
Data

Enables retrospective analysis and investigations

About AgentSCREEN™

ICH Q5A(R2) guidelines encourage the use of Next Generation Sequencing (NGS) as a replacement for in-vivo tests for adventitious virus detection, recognizing its higher sensitivity and reduced testing time. AgentSCREEN™ is a transcriptomic approach with a 28-day turn-around time. The assay examines all the messenger RNA (mRNA) in a cell bank sample for the presence of viral RNA transcripts. The method is designed to detect any active viral infection from both RNA and DNA viruses.

The Minaris next generation sequencing system utilizes 21 CRF part 11 compliant software that provides an audit trail, data integrity and security to ensure adherence to FDA regulations. A custom GAMP5 validated bioinformatics pipeline compares AgentSCREEN sequencing data to the Reference Viral Database (RVDB) curated by CBER/FDA to accurately identify viral contaminants.

The method provides broad virus detection for unexpected viral contaminations to replace in-vivo tests and can complement in-vitro cell culture assays. If an unanticipated positive signal occurs, Minaris has the ability to perform a full investigation including expert virology review and orthogonal assays.

AgentSCREEN™ NGS Transcriptome

Test Cells

RNA Extraction

cDNA Library Preparation

Quality Control Check

ATGTCAACC Sequencing

Quality Control Check

BioInformatics

Explore All
Minaris Services

Contact Us

Accurate, timely, and compliant testing is critical to advancing complex therapies. Minaris Advanced Testing delivers a comprehensive suite of GMP biosafety and characterization services designed to support every stage of your program, from early research through IND, clinical and commercial requirements. Our team provides the experience, responsiveness and support you need. Get in touch today.

Get in Touch