Precision biomarker analysis for biologics & gene therapy

Biomarker Services

Avantia Labs delivers quantitative & qualitative biomarker profiling using ligand-binding, immunoassay, and molecular platforms—with GLP/GCLP rigor and 21 CFR Part 11 compliance.

Biomarkers that translate data into decisions.

Avantia Labs delivers high-precision biomarker analysis supporting biologics, vaccines, and gene therapy programs from discovery to clinical development.
Our scientists combine ligand-binding, immunoassay, and molecular platforms to reveal pharmacodynamic effects, safety profiles, and immunogenicity risks — empowering data-driven therapeutic insights.

What we help you achieve

Comprehensive biomarker strategy | GLP/GCLP-compliant bioanalysis | Regulatory-ready data | Precision insights for translational research

Target Partners
  • Biotech & Pharma Companies
  • Academic Translational Centers
  • Clinical Research Organizations
  • Gene & Cell Therapy Developers
  • Diagnostic Innovators
Our Specialties
  • Quantitative Immunoassays (ELISA / MSD / Luminex)
  • Molecular Biomarker Testing (ddPCR / qPCR)
  • Flow Cytometry & Cell-Based Assays
  • Multiplex Cytokine Panels
  • Method Validation & Data Interpretation
Featured Studies
  • Immunogenicity & Translational Biomarkers
  • PK/PD Correlation Studies
  • Early Safety Signal Detection
  • Clinical Efficacy Assessment
Recognized Strengths
  • GLP/GCLP-Compliant Operations
  • Rapid Method Development & Transfer
  • Deep Expertise in Biologics & CGT Programs
  • 21 CFR Part 11-Compliant Data Systems
  • Strong QA & Regulatory Alignment

Biomarker Analysis Process: From Discovery to Clinical Validation

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01. Discovery & Feasibility

Avantia Labs begins with a focused biomarker feasibility assessment to identify optimal analytes, assay platforms, and matrices.
We evaluate sensitivity, stability, and biological relevance to ensure your biomarker program starts with a solid scientific foundation.

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02. Method Development & Validation

Our scientists develop fit-for-purpose assays using ELISA, MSD, and ddPCR, validated under GLP/GCLP and FDA/EMA guidelines to ensure precision, accuracy, and reproducibility.

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03. Clinical Analysis & Interpretation

Our team performs high-throughput clinical biomarker analysis with full data integrity.
We integrate PK/PD correlation and mechanistic interpretation to deliver actionable results that drive clinical and regulatory decisions.

Quality. Sensitivity. Translational Value

Comprehensive Biomarker Solutions for Biologics and Gene Therapy

1

Biomarker Strategy

Designing fit-for-purpose biomarker plans across discovery to clinical phases.
2

Immunoassays

ELISA, MSD, and Luminex for sensitive quantification of pharmacodynamic and immune markers.
3

Molecular Testing

ddPCR and qPCR for accurate nucleic-acid biomarker measurement in CGT studies.
4

Cell-Based Assays

Flow cytometry and functional testing for immune profiling and mechanistic insight.
5

Multiplex Panels

High-throughput cytokine and chemokine analysis for exploratory biomarker discovery.
6

Regulatory Data Support

GLP/GCLP-compliant review and reporting ready for FDA/EMA submissions.

Accelerate Your Biomarker Program with Scientific Precision

Partner with Avantia Labs to turn complex biomarker data into actionable clinical insights.