Navigating the Immunogenicity Lifecycle: Strategies for ADA, nAb & Cytokine Profiling
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For developers of biologics, cell therapies, and vaccines, “How immunogenic is my drug?” is one of the most critical questions in the development pipeline. An unwanted immune response can compromise safety, alter pharmacokinetics, and neutralize therapeutic efficacy.
Answering this question requires more than a single assay. It demands a comprehensive lifecycle approach that looks beyond simple Anti-Drug Antibodies (ADA) to characterize the full breadth of the immune response. At Accelevir, we provide a complete suite of immunogenicity testing services designed to detect, characterize, and monitor these complex interactions.
The Foundation: Tiered ADA, PK, & nAb Assays
The core of any immunogenicity program is a robust, multi-tiered testing strategy. We offer end-to-end support for ADA (Anti-Drug Antibody) assessment, available in both cell-based and plate-based formats.
- Screening & Confirmatory Assays: Highly sensitive detection of binding antibodies.
- Neutralizing Antibody (nAb) Assays: Critical characterization to determine if ADAs are inhibiting the drug’s biological activity.
- PK Integration: Correlation of immunogenicity data with Pharmacokinetic (PK) profiles to assess clinical impact.
Beyond Binding: Soluble Cytokine Profiling
Immunogenicity often manifests as systemic inflammation or Cytokine Release Syndrome (CRS), particularly in cell and gene therapies. To monitor these risks, we utilize advanced soluble cytokine profiling platforms.
Using industry-standard technologies like MSD (Meso Scale Discovery), Luminex, and ELISA, we can simultaneously quantify multiple cytokines and chemokines. This multiplex capability allows for the rapid detection of “cytokine storms” and provides a detailed map of the inflammatory landscape post-dosing.
Monitoring Cellular Immune Responses
Antibodies are only half the story. A complete immunogenicity profile must also account for the cellular arm of the immune system. We provide specialized assays to measure antigen-specific T cell and B cell responses.
- ELISpot & FluoroSpot: These highly sensitive assays allow for the enumeration of cytokine-secreting cells at the single-cell level.
- Antigen-Induced Proliferation: Measuring how immune cells divide and expand in response to your therapeutic.
Deep Mechanistic Insights: Transcriptomics (RNAseq)
For programs requiring the deepest level of characterization, we go beyond protein endpoints. We offer Next Generation Sequencing (NGS) capabilities, including Transcriptomics (RNAseq).
By analyzing gene expression patterns, we can uncover the underlying immune signaling pathways triggered by your drug. This genomic insight helps elucidate the mechanism of action (MoA) behind immune adverse events and informs the design of safer therapeutics.
Partner with an Expert Immunology CRO
Whether you are developing an ADC, a monoclonal antibody, or a novel gene therapy, you need a partner who sees the whole picture. Accelevir integrates ADA, cytokine, cellular, and genomic data to provide a holistic view of your product’s immunogenic potential.
Ready to build a comprehensive testing strategy? Start your project with Accelevir today.