Unchained Labs Stunner High-Throughput Concentration and Particle Size Analyzer
| Brand | Unchained Labs |
|---|---|
| Origin | USA |
| Manufacturer Type | Authorized Distributor |
| Origin Category | Imported |
| Model | Stunner |
| Pricing | Available Upon Request |
Overview
The Unchained Labs Stunner High-Throughput Concentration and Particle Size Analyzer is an integrated benchtop instrument engineered for rapid, label-free biophysical characterization of therapeutic nanoparticles and biomolecules. It combines ultraviolet–visible (UV/Vis) absorbance spectroscopy, dynamic light scattering (DLS), and static light scattering (SLS) in a single optical path—enabling simultaneous quantification of concentration, hydrodynamic diameter, polydispersity index (PDI), molecular weight, mass concentration, aggregate content, and total RNA load—all from a single 2 µL sample. Unlike conventional workflows requiring separate instruments and multiple dilutions, the Stunner eliminates inter-assay variability by co-localizing measurements under identical buffer and temperature conditions. Its measurement principle leverages Mie theory-corrected DLS for sub-10 nm to >1 µm particle sizing, Beer–Lambert law-based UV/Vis for protein or nucleic acid quantitation (e.g., A280, A260/A280 ratio), and SLS-derived Rayleigh–Gans–Debye scattering intensity for absolute mass determination. This architecture supports regulatory-grade data integrity in GMP-aligned environments where traceability, reproducibility, and minimal sample consumption are critical.
Key Features
- Single-injection, multi-parameter analysis: Simultaneous acquisition of concentration (mg/mL), size distribution (nm), polydispersity (PDI), molecular weight (kDa), mass concentration (g/L), and aggregate fraction (%) from one 2 µL sample.
- Integrated UV/Vis + DLS + SLS optics: Co-aligned laser paths ensure spatial and temporal correlation between absorbance and scattering signals—eliminating pipetting-induced errors and cross-sample carryover.
- Automated calibration and drift compensation: Onboard reference standards and real-time thermal stabilization maintain measurement fidelity across ambient temperature fluctuations (15–30 °C).
- GMP-ready software architecture: Compliant with FDA 21 CFR Part 11 requirements—including electronic signatures, audit trails, role-based access control, and data immutability protocols.
- Pre-validated assay templates: Built-in methods for LNP encapsulation efficiency, AAV total capsid titer (via SLS), empty-to-full ratio (via DLS + UV/Vis deconvolution), and protein aggregation kinetics.
Sample Compatibility & Compliance
The Stunner accommodates native, unpurified, and formulation-buffered samples—including lipid nanoparticles (LNPs), monoclonal antibodies (mAbs), viral vectors (AAV, AdV, LV), exosomes, and recombinant proteins—without dilution or labeling. Sample compatibility extends to high-salt buffers (up to 500 mM NaCl), glycerol-containing formulations (≤10% v/v), and opaque suspensions (OD350 ≤ 1.5). All measurements adhere to ISO 22412:2017 (DLS), USP (subvisible particles), and ICH Q5A(R2) guidelines for viral vector characterization. Instrument qualification documentation (IQ/OQ/PQ) is provided per ASTM E2500-13 and supports GLP/GMP audits.
Software & Data Management
StunnerControl™ software provides a secure, validated platform for method development, execution, and reporting. Raw scattering and absorbance spectra are stored in vendor-neutral HDF5 format with embedded metadata (instrument ID, operator, timestamp, environmental logs). Batch processing supports statistical comparison across runs using ANOVA or PCA-driven clustering. Export options include CSV, PDF analytical reports, and structured XML for LIMS integration. All data changes are logged with user ID, action type, and pre-/post-value—fully satisfying ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).
Applications
- Lipid nanoparticle (LNP) development: Quantify encapsulation efficiency, particle stability under freeze-thaw cycles, and batch-to-batch consistency in mRNA-LNP formulations.
- Viral vector QC: Determine total capsid titer (SLS), empty/full ratio (DLS peak deconvolution + A260/A280), and aggregation propensity during purification and fill-finish.
- Protein therapeutics: Monitor thermal or chemical stress-induced oligomerization, assess fragment formation, and validate SEC-MALS correlation without column calibration.
- Early-stage bioprocess screening: Rank clone candidates based on soluble expression yield, monodispersity, and intrinsic viscosity—reducing downstream purification bottlenecks.
- Regulatory submissions: Generate ICH-compliant datasets for IND/BLA dossiers, including method validation summaries (precision, accuracy, robustness per ICH Q2(R2)).
FAQ
What sample volume is required for a full Stunner analysis?
A single 2 µL sample is sufficient for concurrent UV/Vis, DLS, and SLS measurements.
Can the Stunner distinguish between empty and full AAV capsids?
Yes—using combined DLS size distribution analysis and UV/Vis absorbance ratios (A260/A280), the system calculates empty-to-full ratios with demonstrated correlation to TEM and AUC.
Is method transfer possible between Stunner instruments?
Yes—hardware-standardized optics, factory-calibrated detectors, and version-controlled firmware ensure inter-instrument comparability within ±3% for size and ±5% for concentration.
Does the system support 96-well plate automation?
The Stunner integrates with third-party liquid handlers via standard RS-232 and TTL I/O; plate-based workflows require optional StunnerPlate accessory module.
How is data integrity ensured during remote operation?
All remote sessions are authenticated via LDAP/Active Directory, encrypted with TLS 1.2+, and recorded in immutable audit trails synchronized with enterprise time servers.
