SIAT^® Immunogenicity Analysis Service for Autoimmune Disease

Introduction Available Assays Features FAQ Resources

With evolving protein therapeutic platforms, newer biopharmaceuticals have been developed as important pharmaceuticals for the treatment of multiple diseases. The safety and efficacy of biological candidates are critical to their clinical success. However, the proteinaceous nature of many drug candidates can lead to an immunogenic response in the patient. As a pioneer company offering immunogenicity assessment services, Creative Biolabs is capable of providing high-quality immunogenicity analysis services of drug candidates for the treatment of autoimmune disease.

Factors Influencing the Immunogenicity of Biopharmaceuticals

It has been reported that a number of factors could influence the immunogenicity of biopharmaceuticals. In terms of the drug, the presence of nonhuman sequences or novel epitopes generated by amino acid substitution designed to enhance stability, or novel epitopes created at the junction of fusion proteins may contribute to the appearance of immunogenicity response. In addition, molecular structure, changes in glycosylation, can also influence the immunogenicity of a biopharmaceutical. Once the immune system is activated, the efficacy of the biotherapeutic declines as the system attempts to clear the antigen. The immune response itself affects product safety as cytokine release can be toxic. For biotherapeutic development, avoiding this response is vital for success.

Available Assays for Immunogenicity Predication

Animal testing has been used in an effort to assess the potential immunogenicity of biotherapeutic and protein candidates. Even though helpful to researchers, it is often not a good indicator of what the human immune response will be to the biological candidate. Currently, in silico and in vitro assays are the most widely used methods to assess potential immunogenicity of biotherapeutics. Based on sequence information and structural bioinformatics, in silico assay provides a predictive tool to help determine the likelihood of peptide/HLA binding, a condition necessary for T cell activation. While, in vitro approach utilizes a high throughput, multi-parameter approach to analyze T and B cell responses to the drug candidate. At Creative Biolabs, we offer a full package of assays for potential immunogenicity prediction, which including but not limited to Flow Cytometry, ELISPOT, and ELISA.

Features of Our Services

Expertise scientists in immunogenicity assessment
Relative low price with best after-sale service
One-stop service with fast turn-around time

Creative Biolabs is committed to offering tailor-designed immunogenicity assessment services to meet our global customers’ needs in a fast, reliable and affordable way. If you are interested in our service to support your development program, please contact us by sending us your detailed request to e-mail. Our scientists will get in touch with you as soon as possible.

Other optional immunogenicity analysis services for immune-related diseases:

FAQ

What is immunogenicity analysis in the context of autoimmune diseases?
Immunogenicity analysis for autoimmune diseases evaluates how the immune system reacts to therapeutic proteins or biologics intended to treat these conditions. It involves assessing whether the immune system recognizes these treatments as foreign, potentially triggering an immune response that can affect the efficacy and safety of the medication.
How do you measure immunogenicity in autoimmune disease therapies?
Immunogenicity in autoimmune disease therapies is typically measured using assays that detect ADAs. These include enzyme-linked immunosorbent assays (ELISA), radioimmunoassays (RIA), and electrochemiluminescence (ECL) assays. These tests determine the presence and concentration of ADAs that may interfere with the therapeutic proteins.
What impact does immunogenicity have on the effectiveness of autoimmune disease treatments?
Immunogenicity can significantly reduce the effectiveness of treatments by leading to the formation of ADAs that neutralize the therapeutic agents. This can result in a loss of response over time, requiring dosage adjustments or a switch to alternative therapies, complicating disease management.
How can immunogenicity be minimized in autoimmune therapies?
Immunogenicity in autoimmune therapies can be minimized by modifying the therapeutic proteins to reduce their immunogenic potential, using human or humanized proteins instead of murine ones to decrease foreignness, employing immunosuppressive co-treatments, and optimizing administration routes and regimens to reduce immune system exposure.