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All Testing Services

Comprehensive Testing for Biologics, Cell Therapies, Vaccines and Viral Vector Programs
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Minaris Advanced Testing provides one of the most expansive testing service portfolios available for biologics, spanning molecular, virology, microbiology and bio-analytical testing methods.

Backed by decades of experience and a 140,000 ft² cGMP testing facility, our services range from early-phase assay development through commercial release, with harmonized systems to support global regulatory submissions. Our experienced team offers the scientific rigor and operational flexibility required to accelerate your testing strategy and reduce time to patient.

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ALL TESTING SERVICES

Our Core Testing Services

  • Analytical Development

    Analytical Development

    Designing and optimizing analytical methods that meet both regulatory requirements and your product’s unique attributes. Our scientists collaborate with your team to establish phase-appropriate control strategies and support CMC development across all stages.

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  • Assay Transfer

    Assay Transfer

    Efficient and compliant transfer of client-developed or vendor assays into our platform. We perform gap assessments, bridging studies and full qualification or validation to ensure reproducibility and performance in our labs.

    Learn About Assay Transfer

  • Biosafety Testing

    Biosafety Testing

    Comprehensive biosafety services for viral, bacterial and mycoplasma detection, including in vitro, in vivo and molecular assays, to support regulatory submissions and mitigate contamination risk.

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  • Cell Line Characterization

    Cell Line Characterization

    Extensive characterization of Research Cell Banks (RCBs), Master Cell Banks (MCBs) and Working Cell Banks (WCBs) to ensure product identity, purity and stability. Our packages support both research-use and GMP-compliant cell banking.

    Learn About Cell Line Characterization

  • Lot Release

    Lot Release

    Rapid, reliable lot release testing tailored to CGT, viral vector, protein and vaccine products. Services include identity, purity, sterility, endotoxin and potency testing to ensure product readiness.
    Explore Lot Release Services

  • Potency

    Potency

    Development and execution of phase-appropriate potency assays to measure biological activity. Services include cell-based assays with various endpoint analyses such as ddPCR, ELISA, flow cytometry and more.

    Learn About Potency Services

  • Stability

    Stability

    ICH-compliant stability programs, including real-time and accelerated studies, to support shelf-life claims and storage condition determinations for clinical and commercial products.

    Explore Stability Services

  • Viral Clearance

    Viral Clearance

    Design and execution of viral clearance studies using orthogonal approaches, including chromatography, filtration and inactivation steps, with data packages suitable for global regulatory agencies.

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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 Services

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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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