Analytical Development

Analytical Development
Assay Design, Optimization and Validation for Complex Biologics
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Analytical development is foundational to the successful commercialization of any biologic. At Minaris Advanced Testing, our dedicated analytical sciences teams work in parallel with your process and manufacturing functions to design phase-appropriate solutions. These regulatory-aligned assays ensure product quality, consistency and safety from first-in-human through licensure.

We offer testing services across the spectrum of biologics, including gene-edited cell therapies, viral vectors and other advanced therapeutic platforms, and offer standalone or integrated analytical development services tailored to your product’s unique attributes.

Our team brings together deep expertise in biologics characterization, method lifecycle management and regulatory documentation to support your program through clinical development and beyond.

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ANALYTICAL DEVELOPMENT

Full Lifecycle Analytical Support

Minaris provides comprehensive analytical development services for the full assay lifecycle, including:

Assay design and development for novel products and custom formats

Method optimization and qualification

Validation of phase-appropriate methods in compliance with ICH and global regulatory guidelines

Bridging studies and comparability protocols for manufacturing changes

Assay transfer to QC laboratories for long-term GMP performance

Stability-indicating method development to support shelf-life claims

Support for PPQ and commercial readiness documentation

All analytical programs are paired with regulatory strategy and QA support to align with submission requirements in the US, EU and Asia.

Expertise Across Modalities and Assay Types

Our scientists are experienced in the analytical demands of advanced biologics, including:

  • Potency assays (cell-based, reporter gene, qPCR/ddPCR, ELISA)
  • Purity and identity assays (flow cytometry, electrophoresis, PCR-based methods)
  • Safety assays (sterility, mycoplasma, endotoxin)
  • Stability assays under ICH-compliant conditions
  • Product- and platform-specific assays for viral vectors (AAV, LVV), gene-edited cells, mAbs and recombinant proteins
We routinely develop and transfer both compendial and client-proprietary methods, with a deep understanding of product-specific critical quality attributes (CQAs) and control strategies.

Integrated with Development, Manufacturing and Testing

Analytical development at Minaris is not siloed. It is fully embedded within our CDMO and Advanced Testing operations, enabling close alignment with process development, tech transfer and lot release testing.

Our approach ensures that assays developed in the lab perform reliably in the GMP setting, reducing variability, minimizing rework and accelerating time to clinical or commercial release.

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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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