Gyros AB, has announced the completion of a development program initiated to fulfill the requirements of scientists using the Company’s immunoassay platform in the biopharmaceutical industry.
The development program has seen the release of a number of software modules and services to augment the company’s product portfolio, to provide enhanced functionality for users of Gyrolab™ xP workstations, and to further facilitate the use of the platform in regulated environments.
Software modules, such as the Gyrolab LIMS Interface to enable networking and Gyrolab Control Report to generate non-editable result files of raw data, as demanded by regulatory authorities, enable users to upgrade their workstations and retain 21 CFR Part 11 compliance.
Also available is a Gyrolab Functionality Check Kit to check instrument performance within minutes - again in compliance with regulatory demands. To save more time, the Company also offers support for Installation Qualification/Operational Qualification (IQ/OQ) and Performance Qualification (PQ) guidance.
Attendees at the recent European Gyrolab Seminar were able to preview the latest release: the Gyrolab Viewer module that enables the binding profile of each data point to be displayed together with sample and run information.
The ability to see and compare individual binding profiles, a unique feature of the Gyros immunoassay platform, enables users to easily and quickly select optimal reagents during assay development as well as providing a troubleshooting tool for quality control.
Commenting on the announcement, Erik Walldén, President and Chief Executive Officer of Gyros AB, said: “An international installed base confirms that our immunoassay platform is becoming an established technology for bioanalysis throughout the biotherapeutic workflow. It is therefore critical to ensure that our clients have all the support they need to transfer immunoassays downstream from research and development through to regulated GxP environments or between sites. As well as broadening our product offering, this program supports our long term objective of setting the industry standard for transforming the performance of immunoassays within the biopharmaceutical industry.”