Services

Analytical Design, Development & Testing

Building the Data Picture to Support Decision Success

We develop comprehensive, IND-enabling, in-house analytics alongside the process within the ICH Q2(R2) framework, so critical decisions are backed by data ready to transfer to GMP manufacturing. Assays employed too late, or not rigorously designed, controlled, and evaluated, create blind spots that don’t surface until IND filing or a batch failure reveals the issue—building them in parallel closes that gap.

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Analytical Capabilities

NueCell assay development combines foundational and advanced analytical methods and is coordinated with process development. Assays can be qualified to IND-ready standards in alignment with ICH Q2(R2), supported by strategic outsourcing of specialized and compendial testing.

Identity, genetic integrity, and residual process-related impurities, confirmed across every modality we support

Modality-appropriate functional readouts, from cytotoxicity and cytokine secretion to electrophysiological and contractile function

Sterility, mycoplasma, endotoxin, and adventitious agent testing, performed in-house and outsourced as appropriate

Real-time and accelerated stability programs, plus cross-scale comparability panels

Live-cell imaging and AI/ML-enabled image analysis for earlier, data-driven decisions

Assay Categories

  • Flow Cytometry

    Phenotypic characterization, identity, purity, subpopulation profiling across all cell types.

  • Cell Characterization

    STR identity, karyotype, copy number, and zygosity confirmation, plus residual reprogramming factor and residual iPSC testing (LoD-defined) for iPSC-derived programs.

  • Potency & Functional Assays

    Cytotoxicity, cytokine secretion, target-specific killing, co-culture readouts, and functional potency assessment.

  • Genetic Characterization

    ddPCR (VCN) and NGS (integration site analysis) for vector integration and copy number.

  • Safety & Sterility Testing

    Sterility, mycoplasma, endotoxin; rapid methods performed in-house, compendial methods outsourced.

  • Cytokine Secretion Analysis

    Multiplex profiling (Luminex) and ELISAs.

  • Virology & Vector Titer

    p24 ELISA, functional titer, and physical particle characterization.

  • Stability Studies

    Real-time and accelerated programs, including shipping and freeze-thaw studies.

  • Cell Count & Viability

    Fit-for-purpose counting methods translatable to GMP environments.

  • ICC (Immunocytochemistry)

    Protein localization and co-localization with qualitative image analysis.

  • Residual Bead Detection

    Post-selection bead quantification to support release specifications.

  • Live Cell Imaging

    Real-time, label-free kinetic analysis of cell behavior, killing assays, migration, and proliferation.

Expertise

OUR EXPERTISE

Wide-Ranging Modality Expertise

Cell Types

  • Primary cells (T, NK, Myeloid, etc.)
  • Stem & progenitor cells (HSC, PSC, MSC, etc.)
  • Specialized cells (differentiated stem cells, primary therapeutic cells)

Product architecture

  • Autologous
  • Adherent
  • Scale-up
  • Allogeneic
  • Suspension
  • Scale-out

Engineering Capabilities

  • Gene editing
  • Viral delivery
  • Non-viral delivery
  • Cellular reprogramming

Explore Our Other Capabilities

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Let’s Bridge Your Science to GMP

Tell us about your program. Our team will respond within two business days with an actionable plan and clear next steps — no procurement gauntlet, no boilerplate.

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