Immunogenicity Testing for Autoimmune Diseases

Creative Biolabs is an undisputed global leader in the field of drug development for autoimmune diseases. Based on our extensive experience, advanced platforms, and powerful technologies, our scientists have deep expertise in designing, optimizing, and validating immunogenicity testing and offer the best-fit immunogenicity testing procedures for our customers all over the world.

The immune response triggered by the therapeutics or its delivery vehicle can impact the drug pharmacokinetics, pharmacodynamics response, clinical efficacy, and patient safety. Thus, immunogenicity testing plays a crucial role in measuring the immune response elicited during drug development. The goal of all these immunogenicity tests is, ultimately, to measure adverse immune responses generated by antibody drugs and predict the clinical effect of patient immune responses to biotherapeutics.

Immunogenicity testing is challenging because of multiple interactions between the drug, target, and sample matrices. As such, a well-thought-out and well-executed program is a key to producing safe and efficacious biologic therapies for further optimization and validation. Often a single drug requires a panel of assays to create a thorough picture of potential immunogenicity.

Immunogenicity Testing at Creative Biolabs

Creative Biolabs has the expertise and resources to develop and validate methods and perform sample analysis to help you thoroughly study the immunogenicity of your novel antibody drugs in discovery, preclinical, and clinical stages. We have systematically developed fully validated testing to assess the immunogenicity of antibody drugs. Our immunogenicity testing services include the following procedures to meet different demands:

• Total antibody testing
• Neutralizing antibody testing (e.g., cell-based assay, receptor binding assay, and competitive ligand binding assay)
• Critical reagent characterization
• Protein aggregation analysis

Enzyme-linked immunosorbent assay (ELISA) Electrochemiluminescence (ECL) Radioimmunoassay
(RIA) Surface plasmon resonance Analytical Platforms for Immunogenicity Testing

Our immunogenicity testing, which is highly optimized for sensitivity, specificity, precision, and robustness, enables a proper understanding of the immunogenicity, safety, and efficacy of therapeutic antibodies for autoimmune diseases. Besides, we also help our customers develop custom immunogenicity testing (including method development, optimization, and validation) by checking the risk or safety profile of the antibody and the intended purpose of the drugs.

Features of Immunogenicity Testing Services

• Sufficient sensitivity and specificity
• High quality and reproducibility
• Free from confounding interference

Immunogenicity testing provides a way to measure the potential immune responses of drugs. With several years of experience within immunogenicity testing, veteran scientists at Creative Biolabs have worked on a variety of strategies to provide highly sensitive and selective immunogenicity testing for our global customers. To learn more about our immunogenicity testing services, please do not hesitate to contact us.

For Research Use Only | Not For Clinical Use