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Excelitas Technologies Corp. - X-Cite Vitae LB 11/24

Mass Photometry Software

Refeyn Ltd.Request Info
 
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The SamuxMP software package for Good Manufacturing Practice (GMP) from Refeyn Ltd. expands the application of its SamuxMP and SamuxMP auto mass photometers in adeno-associated virus (AAV)-based gene therapy manufacturing facilities.

The SamuxMP instruments are optimized for AAV analytics, offering rapid and accurate measurements of empty-to-full AAV ratios with minimal sample requirements. Mass photometry technology provides high-precision molecular mass measurements at the single-molecule level. The software package ensures compliance with FDA 21 CFR 11 and EMA Annex 11 regulations, enabling mass photometry integration in GMP-regulated environments. The software includes applications for user access control, audit trails, standardized workflows, and electronic signatures, ensuring data traceability and integrity during AAV analytics.



Published: August 2023
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