Immunogenicity Testing - Creative Bioarray

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Immunogenicity is an attribute of a therapeutic product that is often considered a liability. It is the undesired ability of a drug to induce or sensitize the immune system to produce Anti-Drug Antibodies (ADAs), which may neutralize the biological activity of the drug, alter its pharmacokinetics, or cause serious adverse events. A robust immunogenicity strategy is a critical component of any novel therapeutic program, and even more so with advanced biologic modalities, as understanding and controlling immune responses is crucial for the safe and efficacious use of these drugs.

Creative Bioarray offers high-quality immunogenicity assessment services to support the safe and effective development of your next generation biologic therapies.

Our Immunogenicity Testing Service

Supported Product Types

We support a wide variety of therapeutic modalities and have validated assays for the following:

Peptides and recombinant proteins
Monoclonal, bispecific, and multispecific antibodies
Antibody–drug conjugates (ADCs)
Fusion proteins and engineered scaffolds
Gene therapy products (AAV, LV, mRNA)
Oligonucleotide therapeutics (ASO, siRNA, ssRNA)
Cell therapies and ex vivo–modified products
Biosimilars and comparability studies

Assays for the following types of immunogenicity are available:

Anti-Drug Antibody (ADA) Detection and Characterization
Neutralizing Antibody (NAb) Assays
T-Cell Immunogenicity Assessment
Cytokine Release and Immune Activation Panels

Technology Platforms

Our state-of-the-art laboratories support precise, multi-parameter immunogenicity analysis through:

Flow Cytometry (High-parameter panels)

Immune phenotyping, activation markers, receptor occupancy, functional signaling

Cytokine & Chemokine Profiling

Multiplex immunoassays, ELISA, ultra-sensitive detection modalities

Microscopy & High-Content Imaging

Cellular morphology, spatial distribution, pathway activation

Gene Expression and Transcriptomic Analysis

qPCR, bulk RNA-seq, targeted immune panels

Why Choose Us

Experienced scientists and assay developers with expertise in biologics and advanced modalities
Flexible assay development for novel, complex or emerging therapeutic modalities
Rapid turn-around time (TAT) and project-dedicated scientific support
End-to-end preclinical solutions integrated with ADME/DMPK, toxicology, bioanalysis

FAQ

When during the drug development process should I start immunogenicity testing?

We recommend starting immunogenicity risk assessment early, during discovery and preclinical drug development. The goal is to identify potential immunogenic "hot spots" early and design/pre-screen protein variants to reduce this risk before proceeding into costly clinical development.

How do you handle drug interference in ADA assays?

Drug interference is a common challenge in ADA assays, and we have a number of mitigation strategies available, both proprietary and standard. These include specialized sample treatment methods (Acid Dissociation, SPEAD, etc.) and assay development/optimization to minimize interference (e.g., high-drug tolerance ADA assay formats, etc.) so that you can still reliably detect ADAs even in the presence of high drug concentrations.

Do you have assays to predict immunogenicity for gene therapies?

Yes. We have a number of assays that can be utilized to evaluate gene therapy products, including both pre-existing and treatment-induced antibodies against the vector (i.e. AAV capsids), as well as assays to evaluate vector-specific T-cell responses using specialized cellular assays.

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