“Using Gyrolab to detect anti-drug antibodies allows for high-throughput screening. And the built-in automation actually gave me more time during the day to focus on other important issues.”
Johanna Mora, Bristol Myers-Squibb, Princeton, NJ, USA
Anti-drug antibody testing
In recent years, the increase in the number of approved therapeutic proteins has resulted in strict regulatory requirements on immunogenicity testing of biopharmaceuticals during clinical trials. Development and validation of increasingly sensitive and increasingly specific anti-drug antibody (ADA) assays is required, in order to enable early detection and characterization of an anti-drug antibody response.
This represents a major undertaking for biopharmaceutical companies, due to the large numbers of patients and samples that need to be screened.
Gyrolab is the optimal tool for the screening of undesirable immune responses and subsequent confirmatory assays. Gyrolab is flexible, can cope with complex matrices and offers excellent reproducibility, while providing higher throughput rates. With GxP support available, it forms a compliant, bioanalytical system that exceeds the performance levels achieved by other antibody-based immunoassays. The small sample and reagent volumes ensure that the consumption of precious ADA-containing samples used for positive controls is kept to an absolute minimum.
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Anti-drug antibody (ADA) testing in clinical populations
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Avoid false–negative results
The combination of high drug tolerance and broad dynamic range drastically reduces the risk of attaining false-negative results due to free-drug interference or prozone effects. Gyrolab enables you to trust your screening results, so that you can concentrate on necessary confirmatory assays.
Increase screening throughput
With results delivered in less than one hour, Gyrolab provides a quick and effective screening process for identifying positive samples. Higher throughput and the ability to run samples overnight, means that analysts are able to carry out other qualified tasks during the day. Robust assays and high levels of automation mean that one person can produce more data of higher quality.
Minimize risk of operator errors
Gyrolab is a simple-to-use, automated system. Automated sample processing precludes the need for human intervention, consequently improving workflow robustness. This also means that the assay is not operator-dependent, therefore, there is virtually no risk of human error and transferability is vastly improved.
