A Mass Photometer For Automated AAV Analysis: SamuxMP Auto
The SamuxMP Auto is the automated mass photometer for AAV characterization, autonomously measuring up to 24 samples in approximately 90 minutes. The instrument rapidly measures AAV empty/full ratios, sample purity and particle aggregation for any AAV serotype – with high precision and reproducibility.
Key Features:
- Rapid characterization of empty/full AAV capsid ratio
- Automated technology - 24 measurements in about 90 min
- Highly reproducible data with minimal sample preparation
- Automation unit retrofittable to the SamuxMP
Characterization of AAV samples
- Empty/full AAV capsid ratio
- Partially filled and overfilled capsids
- Detection of aggregates and impurities
- Rough titer estimation
Automated measurement
- 24 measurements in about 90 min
- High reproducibility
- Automation unit retrofittable to the SamuxMP
Easy setup
- Benchtop instrument
- Minimal sample preparation
- Minimal training required
Key advances of the SamuxMP Auto
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.
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.
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.
Frequently asked questions
- How many samples can the SamuxMP Auto measure autonomously?
It can measure 24 samples autonomously including calibrants. After 24 samples, the glass sample carrier slide must be exchanged manually.
- Can the SamuxMP Auto do in-plate dilutions prior to the measurement?
Yes, it can do dilutions in the 96-well plate. Dilutions are limited to factors that are multiples of 10.
- Do I need to calibrate the SamuxMP Auto? How often?
Yes, we recommend running a calibrant as the first and last sample on every 24-well slide. This will ensure the highest mass accuracy and serve as an internal control. We recommend performing a 1-point calibration with empty AAV capsids of known mass.
- Is the SamuxMP Auto 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.