Key Manufacturers: Refeyn 

Category: Mass Photometry

SamuxMP Auto

The SamuxMP Auto is an automated mass photometer specifically engineered for the characterization of adeno-associated viruses (AAVs) in gene therapy development and manufacturing. Building on the core technology of the standard SamuxMP, this system integrates a liquid-handling robot to autonomously measure up to 24 samples in approximately 90 minutes. (Robotics unit can be retrofitted to SamuxMP instrument)

Key capabilities include:

Rapid Empty/Full Ratio Analysis: Accurately distinguishes between empty, full, and partially filled capsids without the need for large sample volumes or extensive preparation.

High Throughput: Reduces manual operation time by automating sample loading and measurement, ideal for screening and titration assays.

Sample Efficiency: Requires minimal sample volume (10–20 µL) at low concentrations, preserving valuable material.

The system can be deployed within regulated settings through software platforms designed for compatibility with FDA 21 CFR Part 11 and EU GMP Annex 11 requirements (audit trails, user management, electronic records). Instrument hardware itself is not “GMP certified,” but the software ecosystem supports validated use.

Official Websites & Resources

Associated Analytical Procedures

Context in Practice: Example Specifications

From: Typical AAV Drug Product Specifications

This instrument is used in the context of measuring the Quality Attribute Capsid Empty/Full Ratio with the following details:

  • Purpose / Rationale: A key purity and potency attribute, as only full capsids are therapeutically active.
  • Typical Acceptance Criteria: The specification is product-specific and justified by clinical and manufacturing data. It is typically set as a minimum percentage of full capsids (e.g., NLT 25%) or a maximum percentage of empty capsids (e.g., NMT 75%).