Gyrolab software modules add functionality onto the core software suite for additional application-specific
analysis, and are designed with 21 CFR Part 11 compliance in mind.
Automatic electronic generation of non-editable, 21 CFR Part 11 compliant, raw data reports to meet regulatory requirements.
Display and review on-column fluorescence for each datapoint.
Guides the development and validation of immunogenicity assays including ADA screening and confirmatory analysis.
Gyrolab Affinity Software
Facilitates the design and evaluation of in-solution affinity experiments.
Gyrolab LIMS Interface
Enables full integration of Gyrolab systems into a Laboratory Information Management System (LIMS) in
compliance with GxP requirements.
An essential requirement of 21 CFR Part 11 is the generation of non-editable, raw data reports after each run. Gyrolab Control Report module automatically generates non-editable raw data reports after each run, in alignment with 21 CFR Part 11 compliance.
For users who use a LIMS system for data analysis, this module delivers reports that include run and experimental details in pdf format.
Gyrolab Viewer enables visualization of the on-column fluorescence binding profile for each data point, revealing the binding interaction of each analyte with the column. The Gyrolab Viewer profile is a uniquely powerful tool for assay development and troubleshooting.
Gyrolab Viewer is accessed directly through Gyrolab Evaluator to facilitate assay development and troubleshooting from research through regulated environments. Binding profiles from Gyrolab Viewer can also assist in the selection of optimal binding pairs by comparison between data points.
Gyrolab Viewer profiles facilitate assay development and QC data analysis
Assessment of anti-drug antibodies (ADAs) is a fundamental part of immunogenicity testing. Gyrolab ADA Software follows a standard ADA assay workflow of screening followed by confirmatory assays to provide time-efficient, drug-tolerant analysis of anti-drug antibodies (ADA) in serum samples.
The Gyrolab ADA Software module incorporates a cut point formula for automatic data evaluation, displaying data according to predefined acceptance and cut point criteria for clear visualization of results.
Gyrolab ADA Software guides confirmatory analysis by displaying results according to your acceptance criteria and confirmatory cut point. Samples falling outside of acceptance criteria are automatically highlighted.
Gyrolab Affinity Software module guides the design and evaluation of in-solution affinity experiments to determine KD values for up to 14 interacting pairs.
Biopharmaceutical companies and contract research or contract manufacturing organizations (CRO/CMO) companies often require a Laboratory Information Management System (LIMS) interface for sample tracking and data storage. Gyrolab software provides several options for a LIMS interface.
Worklist-mediated, manual Gyrolab run setup
Fully automated LIMS interface