Immunologix Labs is a specialized bioanalytical and biomarker CRO supporting biologics, cell and gene therapies, and nucleic acid-based therapeutics. The company focuses on complex assay strategy, development, validation, and sample analysis for programs that require strong immunogenicity, PK, biomarker, and translational science support.

Overview

Immunologix Labs is built for sponsors developing advanced therapeutic products where standard off-the-shelf bioanalysis is not enough. Their team supports preclinical and clinical programs with integrated laboratory and scientific services across bioanalysis, biomarker testing, immunogenicity, neutralizing antibody assays, flow cytometry, qPCR, and cell-based assay platforms.

For biotech and pharma teams working on biologics, antibodies, cell therapies, gene therapies, and nucleic acid-based medicines, Immunologix provides both the technical execution and the strategic assay guidance needed to support development decisions.

Accreditations & Compliance

Immunologix offers GLP and GCP-compliant laboratory capabilities focused on biomarkers and bioanalysis for biologics, cell and gene therapy, and nucleic acid-based therapeutics. Their work supports regulated preclinical and clinical studies where assay quality, documentation, validation, and scientific context are critical.

The company also announced CLIA registration in 2024, allowing it to support clinical testing workflows that require CLIA oversight.

Core Services

Immunologix provides bioanalytical quantitation services, including PK method development, assay validation, and study sample analysis for large-molecule therapeutics, cell and gene therapy products, and nucleic acid-based biotherapeutics.

Their immunogenicity services include risk assessment, assay strategy, ADA assay development, neutralizing antibody assay support, cell-based assays, ligand binding assays, and clinical-context-driven assay design.

Immunologix also supports biomarker assay development and validation, flow cytometry, qPCR-based assays, critical reagent services, and translational science consulting. Their flow cytometry services include panel design, assay development, validation, sample analysis, data interpretation, cell proliferation, activation, and rare cell analysis.

Technology & Expertise

Immunologix combines ligand binding assays, cell-based assays, qPCR, flow cytometry, biomarker analysis, and translational science expertise to support complex drug development programs. Their model is designed to align the assay strategy with the molecule, disease indication, clinical context, and stage of development.

A key part of their approach is their scientific triad model, where each project is supported by a Principal Investigator, Translational Scientist, and Lead Method Developer. This structure helps connect laboratory execution with broader drug development strategy, especially for complex biologic and advanced therapy programs.

Best Fit Projects

Immunologix Labs is a strong fit for projects involving biologics bioanalysis, large-molecule PK, immunogenicity testing, ADA assays, neutralizing antibody assays, biomarker assay development, flow cytometry, qPCR, cell and gene therapy bioanalysis, biodistribution, pharmacodynamic markers, and translational biomarker strategy.

They are especially well suited for sponsors developing monoclonal antibodies, recombinant proteins, cell therapies, gene therapies, nucleic acid therapeutics, and other complex modalities that require customized assay design rather than a standard testing menu.

Why Work With Immunologix Labs Through CROaccess

Through CROaccess, sponsors can evaluate Immunologix Labs for specialized bioanalytical, immunogenicity, biomarker, and translational assay projects while comparing fit against other qualified CROs and laboratories.

Immunologix brings deep scientific expertise in complex biologic and advanced therapy bioanalysis, while CROaccess helps sponsors manage vendor evaluation, proposal collection, documentation, communication, and project tracking in one centralized platform.