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    • More than 200 therapeutic monoclonal antibodies have been approved worldwide for the treatment of diseases such as cancers, autoimmune diseases, and metabolic disorders. Because of their high specificity, low toxicity, few side effects, and high success rate of development, antibodies have been sought after by many pharmaceutical companies and research institutes. During the drug development, reducing the immunogenicity of antibody therapeutics is one of the most critical challenges. The binding of anti-drug antibodies (ADAs) to circulating drugs and the subsequent formation of immune complexes can affect the pharmacokinetic (PK) and pharmacodynamic (PD) properties of therapeutics, reducing the efficacy and safety of drugs. ADAs can be neutralizing or non-neutralizing. Neutralizing antibodies (NAbs) bind to the drug and inhibit its pharmacological function by interfering with its ability to bind to its target, whereas non-neutralizing antibodies (non-Nabs) bind to sites on the drug that do not affect target binding. In addition to preventing drug binding to its target, the formation of immune complex can affect the total exposure of the drug, thereby increasing clearance.

    The immunogenicity of therapeutic antibodies can be evaluated by detecting and measuring ADAs. Many ADA detection methods are based on immunoassay, including antigen binding test (ABT), electrochemiluminescence (ECL) assay, radioimmunoassay (RIA), enzyme-linked immunosorbent assay (ELISA), etc. ELISA is the most common immunoassay used to detect and measure ADAs. The advantages of employing ELISA include high sensitivity, low cost, ease of use, and high throughput. Many ELISA formats (such as direct, indirect, and bridging) have been used for ADA detection. ADAs may be present in circulation as free antibodies or as part of antibody-drug complexes. A sample may contain additional residual drugs, and the residual drugs bind to ADAs, making detection difficult in most immunoassay formats. Typically, bridging format ELISA can only detect free ADAs and cannot detect ADAs bound to drugs.

    Quantitative and Qualitative ELISA Kits

    Amerigo Scientific offers a wide range of quantitative and qualitative ELISA kits for more than thirty therapeutic antibodies and their ADAs for PK and immunogenicity analysis. The ADA quantitative detection ELISA kits include confirmatory reagents to eliminate false positive results. In addition, total ADA detection ELISA kits for infliximab and adalimumab are developed to measure free and total ADAs simultaneously and allow comparison between total and free ADAs, giving semi-quantitative results. We also offer ELISA kits for the qualitative detection of neutralizing antibodies of Adalimumab, Certolizumab, Infliximab, Rituximab, Ustekinumab, and Vedolizumab.

    All the ELISA kits are validated in accordance with international standards. The dynamic measurement range of each kit is optimized to the Cmax-Cmin values of therapeutic antibodies. Kits can be used to measure the biological levels of drugs in serum or plasma samples from humans, mice, rats, and monkeys for PK studies. Studies in more than 150 publications have used our ELISA kits.

    Features

    • ELISA kits for the analysis of PK and immunogenicity of more than 30 antibody drugs
    • Kits in 96 well format produced under the ISO 13485 quality system with CE-IVD certification
    • Low inter- and intra-assay coefficients of variation (CVs) to fulfill FDA and EMEA requirements
    • High recovery within 85 to 115%
    • Low required sample volume (10-25µl)
    • Short incubation time (70-140 min)
    • Ready-to-use reagents in kits with high stability
    • Shipping at room temperature

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