Immunogenicity & immunotoxicity assesment

Understanding and managing immune responses is a critical part of developing safe and effective biotherapeutics. At SYMBIOSIS, we support immunogenicity and immunotoxicity assessment with high-quality human-derived resources designed for translational relevance.

Infographic summarizes summarizing key factors influencing immunogenicity of biotherapeutics, including molecular properties (e.g., sequence, PTMs, aggregation), product quality attributes, administration route, and patient-specific variables that collectively affect anti-drug antibody formation and adaptive immune responses.

Why immunogenicity & immunotoxicity matter

Immune responses can significantly influence both the efficacy and safety of therapeutic products.

Unwanted immune activation may reduce drug efficacy
Formation of anti-drug antibodies (ADAs) can impact dosing and treatment outcomes
Immune-mediated toxicities may limit clinical development

Early and reliable assessment helps identify risks before they become critical in later development stages.

Immunogenicity

Immunogenicity describes the ability of a substance to trigger an immune response.

This can be:

Desired, for example vaccines
Undesired, particularly for protein-based therapeutics, biologics, or advanced therapies

Potential consequences of unwanted immunogenicity include:

Desired, for example vaccines
Undesired, particularly for protein-based therapeutics, biologics, or advanced therapies
Altered pharmacokinetics
Increased risk of adverse events

Immunotoxicity

Immunotoxicity refers to harmful effects on the immune system caused by a therapeutic compound.

These effects may include:

Immune suppression
Excessive immune activation
Cytokine release
Immune-mediated tissue damage

Immunotoxic effects can occur even when the intended target is correctly addressed, making thorough evaluation essential.

Application areas

Assessment of immunogenicity and immunotoxicity is particularly relevant for:

Biologics and protein therapeutics
Monoclonal antibodies
Vaccines
Cell and gene therapies
Novel therapeutic modalities

At SYMBIOSIS, we focus on providing human-relevant biological materials that enable robust immune safety testing. Our resources support translationally relevant immune response assessment, population-representative testing strategies, and can be flexibly integrated into existing assay platforms.

Human-derived cell resources

SYMBIOSIS offers high-quality human immune cell materials to support immunogenicity and immunotoxicity studies, including:

Peripheral Blood Mononuclear Cells (PBMCs)
HLA-typed donor panels
Cryopreserved and ready-to-use formats

These materials support:

T-cell activation and proliferation assays
Cytokine release studies
Immune profiling and funxtional testing

Bioassay-services

Our bioassay services provide robust testing solutions for both Research Use Only (RUO) applications and studies conducted under Good Laboratory Practice (GLP) conditions, enabling critical insights into cellular and molecular interactions.

Key assays offered:

PBMC stimulation / CD3+ CD4+ proliferation assay
Evaluation of immune responses through stimulation and measurement of CD3+ CD4+ T-cell proliferation derived from peripheral blood mononuclear cells (PBMCs).
DC:CD4+ proliferation assay (MLR)
Assessment of dendritic cell (DC) activation and subsequent CD4+ T-cell proliferation using mixed lymphocyte reaction (MLR) assays.
Restimulation assay
Analysis of immunological memory responses via restimulation of cells previously exposed to antigens or stimuli.
Cytotoxicity assay
Quantification of cellular toxicity or target cell killing capacity, essential for evaluating immune responses and therapeutic candidates.
Phospholipidosis assay
Detection and assessment of compound-induced phospholipidosis, supporting drug safety evaluation and mechanism-of-action studies.

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