Gyros has launched the Gyrolab application, which is designed to increase efficiency when looking for anti-drug antibodies (ADAs) during the development of biotherapeutics.
The application incorporates essential sample pre-treatment steps, used to improve the drug tolerance of an ADA assay (the assay's ability to detect ADAs in the presence of free drug), into an automated, nanolitre-scale assay workflow.
According to the company, overall runtimes are reduced and technical performance is improved compared with alternative techniques.
The new Gyrolab ADA assay format performed well when used with customer samples at beta test sites, producing results that were within the current recommendations for sensitivity in the presence of high free drug concentrations.
The application comprises a new Gyrolab ADA CD, a Rexxip ADA buffer and dedicated 21 CFR Part 11-compliant Gyrolab ADA software that guides the user through the standard ADA analysis workflow from assay development and validation to screening and confirmatory analysis.
Drug tolerance is achieved by subjecting samples to an acidic incubation step to dissociate any drug-ADA complexes.
Samples are then neutralised and assay reagents added prior to measurement.
Automation, together with full control over assay-specific incubation times, ensures consistent performance and facilitates assay validation.
All products are optimised for use with the company's Gyrolab workstation.
