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Anti-Drug Antibody (ADA) Assay is a bioanalytical method that is developed for the detection and quantification of anti-drug antibodies in biological samples. Creative Diagnostics has extensive experience in assay development and can provide custom ADA Assay Services to the clients using our state of the art assay development platform. We optimize assay conditions, improve detection sensitivity, reduce background interference, and provide robust and reproducible ADA assays based on the client's therapeutic and regulatory requirements. The ADA assay is critical in immunogenicity testing, pharmacokinetics, and safety monitoring of biotherapeutics. We provide preclinical and clinical support to our clients by providing high quality and reliable bioanalytical data.
ADA assays are widely used in both preclinical and clinical development to evaluate the immunogenicity of biopharmaceuticals. The ADA assays are conducted in a tiered approach for optimal analysis. A screening assay is done to determine whether or not there is potential ADA present. This is then followed up by a confirmatory assay that is specific to the drug under development. Titer or neutralizing antibody assays are also conducted to determine the concentration of ADA present or to understand the impact of the ADA functionally. The most frequently used ADA assay formats are electrochemiluminescence (ECL), enzyme-linked immunosorbent assay (ELISA), and radioimmunoassay (RIA), with selection dependent on assay sensitivity and specificity, and other regulatory considerations.
BioTek Synergy Neo2
Thermo Scientific Q Exactive™ Orbitrap LC-MS/MS
Biacore T200(Cytiva)
Creative Diagnostics is your trusted partner in offering ADA assay services to detect and quantify anti-drug antibodies (ADA) and determine their influence on the safety and efficacy of the drug. Our extensive scientific experience over the last few decades helps us offer personalized ADA assays. We have a full portfolio of ADA assay technologies to choose from, with the best sensitivity, specificity, and reproducibility for your purpose. We develop ADA assays with a focus on high performance and regulatory compliance for reliable results for research. We provide:
To meet the diverse needs in antibody analysis and diagnostic applications, we provide comprehensive Anti-Drug Antibodies Assay services, covering a variety of detection strategies and advanced technologies. Our services can support downstream functional research, structural characterization, quantitative detection, and the development of therapeutic drugs. Relying on mature detection methods and strict quality control systems, we ensure that the test results are highly sensitive, specific, and stable. Our core services include:
Use highly sensitive and specific immunoassay methods (such as bridge ELISA or ECL) to quickly screen anti-drug antibodies.
Use competitive binding method to confirm the specificity of ADA and effectively distinguish false positive results.
Accurately quantify the concentration changes of ADA to evaluate the intensity and duration of immune response.
Based on cell or cell-free system, it is the key to evaluate the efficacy of biological drugs to evaluate whether ADA will neutralize the biological activity of drugs.
Provide advanced sample pretreatment strategies (such as acid dissociation technology) to eliminate drug interference and improve detection accuracy.
Design and verify the most suitable ADA detection scheme according to drug structure and clinical needs, in compliance with GLP/GMP standards.
Confirm the type of drug to be tested and the testing requirements, and evaluate the feasibility of the project.
Develop a suitable ADA testing plan and select an appropriate testing method.
Build the testing process, complete the reagent configuration and preliminary verification.
Optimize the testing conditions and verify the sensitivity and specificity of the method.
Achieve large-scale testing and provide continuous technical support and after-sales service.
The figure shows the ADA detection curve with high resistance to drug interference synthesized by Creative Diagnostics, which shows that when the drug concentration ranges from 0 to 1000 μg/mL, the ADA signal only slowly decreases from 9500 RLU to 5500 RLU, which is still significantly higher than the background value(<500 RLU), indicating that this method still maintains excellent detection sensitivity and reliability under high drug background.
We perform our assays in drug-tolerant formats, including acid dissociation, immune complex disruption, and optimized sample pretreatment to ensure we can detect antibodies in the presence of high levels of therapeutic drug.
Binding ADA assays detect antibodies that bind the drug. Neutralizing antibody (NAb) assays go a step further to determine if the bound antibodies inhibit the biological activity of the drug to determine clinical relevance.
To use our anti-drug antibodies assay services, please contact Creative Diagnostics, your expert immunology service provider. From research-scale anti-drug antibodies assay services to industrial scale-up, our team is ready to support your R&D innovation.
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