SamuxMP Software Package For GMP-Regulated Environments

The SamuxMP software package, developed by Refeyn Ltd, enhances the use of SamuxMP mass photometers in Good Manufacturing Practice (GMP) regulated environments, specifically AAV-based gene therapy development and manufacturing. Compliant with FDA 21 CFR 11 (US) and EMA Annex 11 (EU), the software manages users, devices, and calibrants while providing detailed audit trails.

The software includes three applications: ManageMP for user management and access control, AcquireMP for data recording and processing, and EvaluateMPS for calibrating and determining AAV ratios. Refeyn's product offers an automated workflow for calibration and analysis, aimed at detecting and analyzing empty, full, and partially-filled AAV particles. Within this workflow, AcquireMP operates the instrument and acquires data, EvaluateMPS determines the AAV ratios, and ManageMP handles system configuration and user access.