SamuxMP software package for GMP
Software solution expands the use of the SamuxMP and the SamuxMP Auto mass photometers to GMP - regulated environments and enables their use within AAV-based gene therapy manufacturing pipelines.
The software package supports compliance with the FDA 21 CFR 11 (US) and EU GMP Annex 11 regulations. It includes three applications: ManageMP, AcquireMP and EvaluateMPS.
The Refeyn service teams also provide installation and operational qualifications (IQ/OQ), as well as documentation and on-site training.
The SamuxMP Auto offers all the advantages of AAV capsid analysis with mass photometry while adding convenience and reproducibility via automated, highly consistent sample manipulation (Fig. 1). It accurately measures empty/full capsid ratios of AAVs, and detects partially filled and overfilled AAVs in heterogeneous samples.
The SamuxMP Auto can autonomously analyze 24 samples in as little as 90 minutes, yet fits on a benchtop. Its integrated software suite allows the user to define measurement protocols, analyzes the 24 measurements on the fly, and makes it easy to plot and export the resulting data in a variety of formats.
The robotics unit can be retrofitted to existing SamuxMP instruments.
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Fig. 1. The SamuxMP Auto offers autonomous and reproducible measurements. The mass histogram above shows the overlay of 22 measurements of different aliquots from the same AAV sample, illustrating the reproducibility of the measurements.
Mass photometry is a bioanalytical technology that measures the mass of individual AAV particles in solution, quickly and using small amounts of sample.
Mass photometry is ideally suited for measurements of empty/full capsid ratios. Filled AAV capsids have greater mass than empty capsids, so they can be readily distinguished from empty capsids on mass photometry histograms (Fig 1).
Figure 1 Mass photometry measurement of AAV capsids (AAVDJ serotype) with SamuxMP. Two distinct peaks are visible: one with lower mass corresponding to empty capsids, and a second with higher mass corresponding to full capsids.
Serotype-agnostic AAV analytics
The SamuxMP mass photometer can measure AAV capsids of any serotype without the need for protocol adjustments.
Figure 2 shows SamuxMP measurements of empty AAV capsids of four different AAV serotypes.
For each sample, the mass photometry measurements with the SamuxMP revealed a single, symmetric peak at the expected mass, confirming that the SamuxMP produces consistent results across serotypes.
Figure 2: Mass photometry measurements of empty AAV capsids of different serotypes on the SamuxMP. Mass histograms for four different AAV serotypes, with the mass and standard deviation calculated from three technical replicates.
