SamuxMP

A mass photometer for AAV analytics

The Refeyn SamuxMP is a mass photometer optimized for adeno-associated virus (AAV) characterization and is an essential analytical tool for laboratories working with AAVs. SamuxMP mass photometry measurements are quick and require very little sample.

The SamuxMP precisely measures the empty/full capsid ratio for AAVs of any serotype as well as the quantities of partially filled and overfilled capsids. It can also detect impurities and aggregation, and give a rough capsid titer estimate as part of the standard data analysis procedure.

• Quantitative characterisation of AAVs of all serotypes
• Easy measurement of empty / full ratio of AAV capsids
• Rapid analysis requiring minimal sample
• User-friendly operation

Transformative AAV analytics

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).

Serotype-agnostic AAV analytics

The SamuxMP mass photometer can measure AAV capsids of any serotype without the need for protocol adjustments.

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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.

SamuxMP software package for GMP

This 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.

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.

Frequently asked questions

01. Can SamuxMP measure partially filled AAV particles?

Yes, the SamuxMP can distinguish empty, partially filled and full AAV particles.

02. Can the SamuxMP estimate the virus titer?

Yes, the SamuxMP has a virus titer estimation function in its analysis software.

03. Do I need to calibrate the SamuxMP? How often?

Yes, we recommend a calibration at least once a day. We recommend performing a 1-point calibration with empty AAV capsids of known mass.

04. Is the SamuxMP GMP compliant?

A software package compliant with FDA and EU GMP Annex 11​ regulations is available for use with the SamuxMP and SamuxMP Auto. In addition, the Refeyn service teams provide installation and operational qualifications (IQ/OQ) for instruments destined to GMP-regulated environments.