Gyros has announced the launch of a Gyrolab application to increase efficiency when looking for anti-drug antibodies (ADAs) during the development of biotherapeutics.
The application incorporates sample-pretreatment steps, used to improve the drug tolerance of an ADA assay, into an automated, nanolitre-scale assay workflow.
The application comprises a new Gyrolab ADA CD, 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.
With the launch of the Gyrolab ADA solution, Gyros has expanded the utility of its immunoassay platform for applications such as pharmacokinetic and pharmacodynamic studies, biomarker monitoring and impurity testing.
