Products & Services
Gyrolab xPand and Gyrolab xPlore™ instruments are delivered with an easy to use, pre-installed software suite providing the functionality to design, run, execute, and analyze automated microfluidic immunoassays.
Gyrolab software is optimized for productivity in and out of the laboratory. Gyrolab Manager is used to plan and set up runs in the lab or remote, Gyrolab Control integrates and automates workflows, and Gyrolab Evaluator provides the power to analyze data and generate reports.
All software programs and modules are designed to meet 21 CFR Part 11 requirements, ensuring straightforward assay development and transfer within regulated environments.
Gyrolab software features in compliance with 21 CFR Part 11 include:
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.
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Software module to integrates Gyrolab system into a LIMS workflow.
Enables automatic generation of 21 CFR Part 11 compliant, non-editable, raw data report after each run.
Provides access to binding profiles of each data point directly from within Gyrolab Evaluator.
Enables analysis of anti-drug antibodies using Gyrolab CDs. Supports ADA assay workflow through development and validation to screening and confirmatory analysis.
Enables Affinity software module from Gyrolab Evaluator.
Laptop computer with a full installation of all Gyrolab software in a simulated instrument software environment. Include Gyrolab User Licenses (P0004955).
Documentation package with requirements and test specifications for Gyrolab Manager, Gyrolab Control, and Gyrolab Evaluator.
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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 LIMS Interface
Fully automated LIMS Interface
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.
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.
Validating new software releases can be time consuming, taking up valuable instrument time to run validations. Gyrolab Software Validation and Simulator Packages provide tools for speeding up validation processes.
Gyrolab Software Simulator Package consists of a PC with a full installation of all Gyrolab software in a simulated instrument software environment. The simulator PC can be used to evaluate new Gyrolab software releases and prepare for software validation without having to upgrade the Gyrolab system in the lab. The PC with the simulator installation may also be used for formal validation of Gyrolab Evaluator and Gyrolab Manager.
Gyrolab Software Validation Package is a documentation package with requirements and test
specifications to facilitate validation of the Gyrolab software packages: Gyrolab Control, Gyrolab
Manager, and Gyrolab Evaluator.
Tools to speed up Gyrolab software validation: