T-Cell, Cytokine, and Flow Cytometry Assays
Immunogenicity assessment is the detection, assessment and prediction of drug-induced immune responses, such as anti-drug antibodies (ADAs), using a collection of different assays. They are important in the biotherapeutics development process because they can impact a lead candidate’s safety, pharmacokinetics, and efficacy. Comprehensive immunogenicity testing helps you guide lead optimization, formulate dosing strategies, comply with regulatory standards, or eliminate promising leads with potential immunogenicity issues.
Develop the Right Immunogenicity Testing Cascade for Your Lead Candidate
At Eurofins Discovery, we offer extensive immunology and drug development expertise to execute a strategic immunogenicity assessment based on your lead candidate’s MoA, modality, format, and regulatory requirements. Our team can develop and validate cell-based assays for sensitive, specific, robust, and reliable immunogenicity assessment.
T-Cell Assays
T-cell assays are immunogenicity assessments that evaluate how a drug candidate may induce T-cell-mediated immune response, including forming ADAs. They are essential because they can predict the risk of immunogenicity and adverse events during clinical testing. They also provide an opportunity to engineer or reoptimize lead candidates to minimize safety risks, increasing the likelihood of clinical success. Eurofins Discovery offers an extensive collection of off-the-shelf or customized T-cell assays to avoid costly, downstream clinical issues.
Cytokine Measurements
Cytokine assays quantify the level of cytokines released by different immune cell populations following biotherapeutic exposure. These assays can identify potentially harmful treatment-induced immune responses, such as cytokine release syndrome (cytokine storm) and other safety issues. Our experts can help quantify the panel of cytokines most important to your program, enabling you to confidently progress your leads.
Flow Cytometry
Flow cytometry provides single-cell level data on different immune cell populations, helping you understand how a biotherapeutic candidate may modulate immune responses. This detailed immune profiling can provide a complete view of cytokine production and immune response, identifying potential safety risks early in development before your lead enters clinical development.
