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Functional Immune Response Characterization

Immune Response Profiling

Phenotype, function and secreted response from one sample, designed as a single study.

Most advanced therapies set off a cascade of immune events, and any single measurement captures only part of it. A cytokine count shows that cells responded but not which subset responded. A phenotype shows which cells are present but not whether they function. A circulating cytokine level describes the systemic environment but not its cellular source. Immune response profiling, often shortened to immune profiling, combines readouts that each capture a different property of the same response, so the data can be read together rather than as separate reports, which supports a clearer understanding of the response.

CAP-accredited, CLIA-certified laboratory

0 CAP/CLIA-certified

One team from protocol design to final report

0 100% scientist-run

High-throughput functional immunology, pilot to larger study

0 Scalable workflows

Immune and molecular readouts paired

0 One PBMC sample
How it reads the immune system

Four Layers, One Connected Story

The immune system responds on several levels at once, so immune response profiling is organized around four layers: phenotype, function, secreted response and molecular state. Each layer can run on its own, but the value comes from designing them together, so that immune profiling results line up by subject, timepoint and T cell subset.

Phenotype

Which immune cells are present

Function

Do the cells respond?

Secreted response

What the immune system releases

Molecular state

What is happening underneath

Phenotype

Flow cytometry immune profiling describes the presence of specific immune cells and what state they are in: lineage, including CD4+ and CD8+ T cells, memory and differentiation status, and activation and exhaustion markers. Panels range from focused designs to deep profiling.

Function

Functional readouts show whether the cells respond. The ELISpot assay is a single-cell readout that counts antigen-specific, cytokine-secreting T cells and reports the result as spot-forming units per million cells. FluoroSpot extends the same principle to several secreted proteins from the same cell. Intracellular cytokine staining identifies which T cell subsets produce which cytokines and whether individual cells are polyfunctional. Proliferation assays show whether antigen-specific cells expand, and a T cell killing assay measures whether effector cells eliminate target cells.

Stable intracellular dye
Secreted response

Multiplex cytokine and chemokine panels measure what the immune system releases, including soluble inflammatory mediators and other biomarkers, which connects cellular activity to the systemic response. Luminex panels and single-analyte ELISA cover the soluble biomarkers.

Molecular state

Where the program needs it, dPCR, qPCR or NGS from the same sample can relate immune function to vector genome persistence, transgene expression or viral load.

Laboratory & scientific team

Our Immune Response Profiling Laboratory and Scientific Team

Our immune response profiling service, a form of functional immune response characterization, combines intracellular cytokine staining (ICS) by flow cytometry, ELISpot and FluoroSpot, T cell proliferation, cytolytic function assays and multiplex cytokine and chemokine panels. Molecular readouts can be added from the same sample when the study question calls for them. Immune profiling of this kind rests on single-cell readouts of antigen-specific T cells, paired with cytokine and chemokine measurements from the same PBMC sample. The service is designed for translational scientists, bioanalytical leads and program teams at biopharma and biotech companies developing cell therapy, gene therapy, RNA therapeutics, vaccines and immunotherapy.

We design immune profiling to detect what a single assay can overlook. In this service, low-level immune responses often means rare antigen-specific T cells, hidden viral signals means vector or viral genomes measured alongside the immune response, and critical biomarkers means the cytokines and cell states that connect the two. Testing runs in a CAP-accredited, CLIA-certified laboratory, and the assays that support clinical trials are analytically qualified, with qualification documentation available to support regulatory filings.

The immune profiling service supports programs across cell therapy (CAR-T, TCR-T and NK), gene therapy (AAV and lentiviral), RNA therapeutics, vaccines and immunotherapy, with custom assay design for CRISPR-based and other first-in-class approaches. For mouse and non-human primate studies, we partner with the vivarium of your choice, then carry the same immune profiling methods into analytically qualified testing for clinical trials in the same laboratory.

 

Immune profiling by ELISpot, ICS and flow cytometry pairs with the other immunology readouts and with dPCR, qPCR or NGS from the same sample, which saves both time and sample. Accelevir is a 100% scientist-run laboratory, with one team from protocol design to final report, so the profiling strategy can adjust when new data raise new questions.

Choosing the right combination

Match the Readout to the Question

Most immune profiling programs use more than one readout. Cytokine secretion and proliferative capacity are related but not interchangeable, and a response can appear strong on one and weak on the other. Reading the readouts together explains shifts that any one of them would miss.

If the question is… The readout
How many antigen-specific cells respond?
ELISpot — well suited to responders that may be rare
Which subsets respond, and are they polyfunctional?
ICS with phenotyping
Can the cells expand?
Proliferation
Can effector cells eliminate targets?
Killing assay
What is the immune system releasing?
Cytokine and chemokine panels
What is happening to the vector, transgene or virus?
Molecular endpoints
The process

From Scientific Question to Decision-Ready Data

STEP 01

Scientific scoping

A scientist-to-scientist conversation about your program’s goals, modality, the critical question for your next milestone, and your samples, species and study stage.

STEP 02

Tailored proposal

An itemized scope and timeline aligned to your study design, including sample volume, qualification and reporting needs.

STEP 03

SOW and e-signature

A streamlined statement of work, ready for quick signature.

STEP 04

Decision-ready data

Data analysis and reporting built for your next milestone, with data from the first sample to the final follow-up visit.

FAQ

Frequently Asked Questions

What is immune response profiling?

Immune response profiling combines several immune readouts on the same study to describe a response from more than one angle: which cells are present, whether they respond, what they produce and what the systemic environment looks like. It is designed to show what any single assay would miss.

Why combine ELISpot, ICS and cytokine multiplex instead of running one assay?

Each assay captures a different property of the response. ELISpot counts antigen-specific cytokine-secreting cells, ICS identifies which subsets produce which cytokines, and multiplex panels describe circulating mediators. Together they explain shifts that any one measurement misses.

What is the difference between ELISpot, FluoroSpot and ICS?

ELISpot reports how many cells secrete a cytokine, as spot-forming units per million cells. FluoroSpot detects several secreted proteins from the same cell. ICS uses flow cytometry to show which subsets make which cytokines and whether individual cells are polyfunctional.

Are these assays run as CLIA tests or as research-use-only?

The assays that support clinical trials are analytically qualified under our quality management system, with qualification documentation available to support regulatory filings. Preclinical and discovery-stage work can be run as research-use-only when the sponsor does not require a quality framework.

Which sample types and species can be profiled?

PBMCs isolated from whole blood or leukopaks, fresh or cryopreserved, are the most common starting material, and other specimen types are reviewed during scoping. For mouse and non-human primate studies, we partner with the vivarium of your choice, and species and sample requirements for each assay are confirmed during scoping.

Can immune profiling be combined with molecular endpoints from the same sample?

Yes. Immune readouts can be paired with dPCR, qPCR or NGS from the same sample, which saves sample and keeps the molecular and immune measurements tied to the same biological state.

How does scoping work?

Scoping starts with a scientist-to-scientist conversation about your modality, the critical question for your next milestone, and your samples, species and study stage. A tailored proposal follows, then a statement of work for e-signature, then decision-ready data.

Related Immunology Resources

Match the Immune Response Profiling Strategy to Your Study Question

Bring your modality, the critical question for your next milestone, your sample types and species, your timeline, and the decision the data must support. Our scientists will scope the immune profiling combination of phenotype, function, secreted response and molecular readouts that answers it.

Accelevir Diagnostics, LLC is a CAP-accredited, CLIA-certified laboratory. Services are provided for research use in support of clinical and preclinical studies and are not intended for diagnostic, therapeutic, prognostic, or patient-management use.
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