Application Of Mass Photometry In GMP-Regulated Environments For Characterization Of AAV Samples

Refeyn has developed SamuxMP and SamuxMP Auto, tools for characterizing Adeno-associated virus (AAV) samples in GMP-regulated environments. The tools come with a software package that ensures compliance with FDA 21 CFR 11 (US) and EU GMP Annex 11 regulations. These packages include EvaluateMPS, AcquireMP, and ManageMP. The software features user management, audit trails, and electronic signatures. Refeyn also provides installation and operational qualifications, documentation, and on-site training. The tools use mass photometry, which is faster and requires less sample than traditional methods, and come with a software package that ensures compliance with FDA 21 CFR 11 (US) and EU GMP Annex 11 regulations. Here you can see all of the benefits of using these mass photometry instruments, as well as gain information on calibrants and standards, IQ/OQ templates, and support for Performance Qualification (PQ).