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SIAT® ADA Assay Sample Analysis

Immunogenicity testing is an important part of the clinical safety assessment of biotech drugs. Drug-induced antibody responses can affect pharmacokinetics, pharmacodynamics, and toxicity. The immunogenicity may be a chimeric biopharmaceutical, or even a humanized molecule and a fully-humanized biopharmaceutical drug. In most cases, immunogenicity is caused by residues in the CDR regions. Creative Biolabs provides you with detailed testing methods and testing techniques in ADA assay sample test and accurate analysis of your samples, in order to enter the clinical trials more quickly, to ensure the safety of a candidate drug.

ADA Assay Sample Detection

Screening assays and specificity assays are typically included, and characterization assays typically include antibody titration and neutralization antibody detection. When applied to a specific study sample, the anti-drug antibody analysis experiment requires two key decision parameters, which are the screening critical point of the screening test and the specific critical point of the specific verification test. The screening critical point contributes to the classification of the anti-drug antibody detection results, the active sample is higher than the screening critical point, and the inactive sample is below the critical point. The active sample is tested positive or negative by a specific confirmation test. The specificity critical point is the amount of sample required to suppress signal passage, that is, the drug-resistant antibody of a specific drug, which needs to be determined by experiments.

ADA assay formats used for cynomolgus monkeys. Fig.1 ADA assay formats used for cynomolgus monkeys. (Carrasco-Triguero, 2016)

Pre-study Verification

Validation tests prior to the start of sample bioanalysis in clinical and non-clinical studies are usually known as pre-study validation, which describes the performance characteristics of analytical methods in terms of both mathematical and quantifiable aspects. After a complete method of development and optimization, the analytical method should be qualified for the corresponding verification. For example, the optimized experimental data indicates that the detection method has potential reliability and is suitable for the corresponding testing requirements.

What Can We Do?

Creative Biolabs owns the most comprehensive testing equipment and testing technology. Please contact us in time about more details and we will be glad to serve you.

Reference

  1. Carrasco-Triguero, M.; et al. Application of a Plug-and-Play Immunogenicity Assay in Cynomolgus Monkey Serum for ADCs at Early Stages of Drug Development. Journal of Immunology Research. 2016: 1-14.

All listed services and products are For Research Use Only. Do Not use in any diagnostic or therapeutic applications.

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