The Aura PTx System is an innovative analytical platform designed to accelerate protein formulation development and stability screening for therapeutic drug development. Combining Backgrounded Membrane Imaging (BMI) and Fluorescence Membrane Microscopy (FMM) with dual fluorescence channels, the system enables rapid detection, counting, and characterization of protein aggregates and excipient degradation products within a single experiment.
Unlike traditional imaging methods that rely solely on particle morphology, Aura PTx can distinguish protein and non-protein particles using fluorescence-based identification. The combination of Thioflavin T (ThT) and BODIPY FL C16 staining enables simultaneous assessment of protein aggregation and polysorbate degradation, two critical indicators of biologic formulation stability.
Requiring only 5 µL of sample and supporting automated 96-well plate workflows, the Aura PTx System is ideally suited for high-throughput formulation screening during early-stage development of therapeutic proteins, monoclonal antibodies, and other biologics.
Key Features
- Combines BMI and FMM technologies in one platform
- Dual fluorescence channels for simultaneous analysis
- Distinguishes protein and non-protein particles
- Detects and quantifies protein aggregates
- Monitors polysorbate degradation
- Simultaneous protein and excipient stability assessment
- Requires only 5 µL sample volume
- Automated 96-well plate workflow
- High-throughput formulation screening
- No cleaning required between measurements
- Fast sample processing and analysis
- Suitable for Design of Experiments (DoE)
- Supports biologics development
- Early detection of formulation stability issues
Technical Specifications
Technology
- Backgrounded Membrane Imaging (BMI)
- Fluorescence Membrane Microscopy (FMM)
- Dual-channel fluorescence detection
Optics
- Objective: 4×
- Resolution: 1.0 pixel/µm
- Imaging area: 24.6 mm²
Particle Detection
- Detectable size range:
- 1 µm (ECD)
- <5 mm (ECD)
Sample Handling
- Minimum sample volume: 5 µL
- Compatible with 96-well plates
- Optimized for high-throughput screening
Analysis Speed
- BMI read time: 1 minute per sample
- FMM read time: 30 seconds per sample
Fluorescence Analysis
- Thioflavin T (ThT) for protein aggregate detection
- BODIPY FL C16 for polysorbate degradation analysis
- Simultaneous protein and excipient characterization
Waters: The Aura PTx System tells you exactly what is protein (via ThT staining) and what is not, even in mixed particles.
Waters: The Aura PTx System is the first to use thioflavin T (ThT) and BODIPY FL C16 staining to detect and quantify protein aggregates and polysorbate breakdown.
Software
- Particle Vue™ 4.x Software Suite
- Integrated data analysis
- Automated particle identification and characterization
Typical Applications
- Biopharmaceutical development
- Protein formulation screening
- Monoclonal antibodies
- Biosimilars
- Stability studies
- Excipient screening
- Polysorbate degradation monitoring
- Aggregate characterization
- Design of Experiments (DoE)
- Biologics quality control
