Launch extends the use of AssayMAP to regulated environments
Agilent Technologies Inc. recently announced the release of the AssayMAP Bravo Protein Sample Prep Workbench 4.0 software. This release adds 21 CFR Part 11 compliance-enabling features that allow AssayMAP Bravo-based automated sample preparation in workflows across the biopharma drug development process.
The requirement for labs to use instruments that comply with regulatory guidelines such as 21 CFR part 11 or have the option of turning on compliance enabling software features is moving to earlier stages of the drug development process. The AssayMAP Workbench 4.0 addresses these requirements and facilitates the seamless transfer of assays along the entire drug development process, including moving from non-compliant to compliant laboratories.
AssayMAP Workbench 4.0 simplifies the documentation required in regulated laboratories and desired in non-regulated labs by providing the option to generate reports that capture sample prep workflow data. The new AssayMAP software also enables novice users to use the system with minimal training by providing the option for walk-up operation.
“The addition of compliance enabling features, walk-up capabilities, and report generation provide our customers added value across the entire biopharma drug development process,” said Lars Kristiansen, general manager of Agilent’s Automation Solutions business. “These enhancements align with our focus to provide new solutions to our biopharma partners that enable them to bring biotherapeutics to market faster and more cost-effectively.”
AssayMAP Workbench 4.0 also expands the software support for the recently released AssayMAP large-capacity cartridges. These cartridges enhance the ability of biopharma labs to analyse biotherapeutic critical quality attributes and enable more complete automation of sample prep workflows.