Immunogenicity refers to the trait of a drug that stimulates the body to form a line of antibodies or sensitized lymphocytes. Evaluation of immunogenicity in preclinical and clinical trials is an important part of biopharmaceuticals. Anti-drug antibodies (ADA) produced after administration may neutralize drug activity, affect drug clearance, plasma half-life, and tissue distribution, and alter pharmacodynamic (PD)/pharmacokinetic (PK) characteristics. Therefore, it is necessary to examine the immunogenicity when evaluating drug safety. Creative Biolabs owns state-of-the-art testing equipment and technology to provide you with the most accurate data on immunogenicity testing.
The ADA method may affect the test results and experimental data by potential interference during the measurement. In actual testing, the interference of this potential experimental data may result from the use of a proxy ADA when testing samples. The choice of an alternative positive control is challenging because no antibody can produce a positive response to all variants of ADA in preclinical studies. The affinity, specificity, and concentration of each antibody will vary. Corresponding in vivo polyclonal reactions can also result in multiple antibodies that react differently. Some of the positive controls used by the proxy ADA are antibodies that have been purified and can be used to stimulate normal serum to cause a positive QC peak in the expected ADA serum. Antibodies can be collected from purified antibodies, or hyperimmune animals and preclinical or clinical trials. From the hyperimmune serum, the ADA positive serum can be identified.
Fig. 1 Bridging immunoassay.1
The generation of antibody class diversity requires not only a combination of multiple analytical methods and platform technologies, but also an increasing demand for the development and validation of accurate and robust bioanalytical methods, and requires that the resulting data stand up to regulatory review. Creative Biolabs owns comprehensive technical information and experimental experience. Please contact us as soon as possible for more information and we will be glad to serve you.
Other optional SIAT® Anti-drug Antibodies (ADA) Assays:
A positive control in an ADA assay is a sample known to contain antibodies against the drug being tested. It is used to demonstrate that the assay is functioning correctly and can detect ADAs if they are present. Positive controls help ensure the reliability and consistency of assay results across different runs and laboratories.
Positive controls for ADA assays are typically generated by immunizing animals (like rabbits or goats) with the therapeutic protein or by isolating antibodies from patients who have developed ADAs. These antibodies are then purified and characterized to ensure their suitability as controls in terms of specificity and reactivity.
A positive control should be highly specific to the drug, with a well-defined affinity and concentration that consistently yields detectable and reproducible results within the assay's dynamic range. It should not cross-react with other components in the assay or with irrelevant targets to avoid false positives.
Human-derived antibodies can be used as positive controls, especially when they are available from patients who have developed ADAs against the therapeutic drug. These antibodies are particularly valuable as they closely represent the human immune response to the drug, providing a realistic assessment of the assay's performance.
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