Biosafety Testing

Biosafety Testing
Comprehensive Biosafety Testing for Advanced Therapies and Biologics
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Biosafety testing is a critical requirement for ensuring the safety and regulatory compliance of biologics and advanced therapy medicinal products (ATMPs). At Minaris Advanced Testing, we provide a broad suite of validated biosafety assays to detect adventitious agents and verify product sterility, helping our clients meet global regulatory expectations with confidence.

We offer biosafety testing both as a standalone service and as a part of our integrated CDMO services for clients across the life sciences industry. Whether you’re a cell and gene therapy developer, vaccine manufacturer, or mAb producer, our biosafety experts provide phase-appropriate solutions to support your program from preclinical through commercial release.

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End-to-End Biosafety Capabilities

Minaris provides GMP-compliant biosafety testing services designed to meet FDA, EMA and PMDA requirements, including:

Sterility Testing

Per USP <71> and Ph. Eur. 2.6.1 using direct inoculation or membrane filtration

Mycoplasma Detection

Per USP <63>, Ph. Eur. 2.6.7 and validated NAT (nucleic acid amplification) methods for rapid turnaround

Endotoxin Testing

Per USP <85> using kinetic chromogenic methods

Adventitious Agent Testing (AAT)

in vitro and in vivo assays for the detection of viral and microbial contaminants

Replication-Competent Virus (RCV) Testing

Lentiviral, Retroviral and AAV replication-competent and detection assays

All tests are performed under GMP protocols with full documentation and audit readiness.

Specialized Focus on Cell & Gene Therapies

Biosafety testing for cell- and gene-modified products requires tailored methods and deep expertise in viral vectors, primary cells and complex manufacturing workflows. Minaris brings decades of CGT experience to every biosafety program, offering:

  • Risk-based testing strategies aligned with viral vector design and production system
  • RCV testing tailored to your specific plasmid construct and packaging cell line
  • Mycoplasma and endotoxin testing integrated directly into GMP batch release workflows
  • Close coordination between biosafety, process development and QC teams for real-time issue resolution
We also offer support for biosafety sections of IND, IMPD and BLA submissions, including assay summaries, validation protocols and test reports.

Investigational
Support

Our analytical sciences team provides advanced technologies to support you if you suspect a viral contaminant in your manufactured biologic. We have methods to identify an adventitious agent or a recombinant, replication-competent vector. These methods can also offer significant value during the development of your product or cell banks. 

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Flexible Engagement Models and Rapid Turnaround

Our biosafety testing services are available through multiple engagement models:

  • As a standalone testing service with sample submission
  • Through rapid-response scheduling for time-sensitive programs
  • For both routine batch release and investigational studies
  • As part of a full CDMO program (development, manufacturing and testing)

We work with clients to ensure sample handling, reporting timelines and regulatory expectations are met without delays.

Ready to Get Started?

Whether you need GMP release testing for a commercial therapy or exploratory analysis for an early-phase asset, we’re here to help. Access our full testing catalogue or submit a sample request today.

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Minaris Advanced Therapies is dedicated to helping innovators in cell and gene therapy succeed. Whether you are in early-stage development or preparing for commercial launch, our end-to-end expertise, global reach and commitment to quality make us the ideal partner for cell and gene therapy manufacturing and GMP biosafety and analytical testing of all biologics.

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