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Testing by Modality

Supporting Innovation Across Therapeutic Modalities and Development Stages
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Minaris Advanced Testing delivers GMP-compliant analytical and biosafety testing to developers of biologics and advanced therapies worldwide. From bioanalytical testing for early-stage programs to GMP lot release testing for commercial products, we provide the scientific rigor, regulatory expertise and technical capabilities required to ensure product quality, safety and compliance.

We specialize in four core markets: monoclonal antibodies and recombinant proteins, cell therapies, viral vectors and vaccines. With over 40 years of biologics testing experience, specialized facilities and a proven record of global regulatory acceptance, we help innovators accelerate timelines, mitigate risk and achieve successful product release.

Cell Therapies

Description Capabilities

Minaris Advanced Testing supports autologous and allogeneic cell therapy programs, including both gene-edited and non-gene-edited modalities. Our rapid, GMP-compliant testing decreases vein-to-vein time and ensures regulatory readiness when co-located with manufacturing facilities.

Monoclonal Antibodies and Recombinant Proteins

Description Capabilities

We provide comprehensive monoclonal antibody testing services for innovator biologics and biosimilars. With harmonized GMP protocols and validated assays, we ensure mAbs meet FDA, EMA and ICH requirements throughout the development lifecycle.

Viral Vectors

Description Capabilities

We support viral vector gene therapy programs with phase-appropriate testing for AAV, lentiviral, adenoviral and other vector platforms. Our services ensure compliance and reduce risk from development through commercial lot release.

Vaccines

Description Capabilities

We partner with vaccine developers to provide GMP-compliant testing for viral vector-based, recombinant protein and emerging vaccine modalities. Our integrated testing services help ensure global compliance from early trials to commercial supply.

Global Reach, Local Expertise

With GMP-certified facilities across the United States, Europe and Asia, Minaris Advanced Testing combines local expertise with global regulatory knowledge. Our flagship 140,000-square-foot cGMP testing facility in Philadelphia is one of the largest dedicated biologics testing campuses in the world, equipped with viral clearance suites, molecular biology, microbiology and advanced analytical labs to support even the most complex programs.

Your Dedicated
Testing Partner

Our scientific leadership has pioneered industry standards in viral clearance, lot release, potency, biosafety and stability testing. With decades of experience in assay development, validation and regulatory submission support, we are committed to delivering reliable, regulatory-ready results.

By combining precision, speed and compliance, we help innovators deliver safe and effective products to patients worldwide.

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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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