Specification_and_Justification.pdf

Specification for nCS1 Particle Analysis System

The following specifications are unique to the Spectradyne nCS1 nanoparticle analysis instrument, and cannot be met by any other supplier:

1. System must be capable of measuring particles from 50nm to 10µm in Equivalent Spherical Diameter (diameter of a sphere of equivalent volume)

2. Should use resistive pulse sensing as its core technology for particle characterization (non-optical)

3. Measurements of particle size should be independent of particle shape (i.e. “volumetric”, with no assumption of shape) and material making up the particle (i.e. no reliance on index of refraction or other material property)

4. System must be able to detect differently-sized populations of nanoparticles in a complex mixture (e.g. multiple components in a drug formulation) and more importantly, accurately report the concentration of each particle size

5. System should use disposable microfluidic cartridges for measurement to prevent cross-contamination and eliminate cleaning

6. Microfluidic cartridges should be made using highly consistent nanoscale features and be factory calibrated for size and concentration measurements, therefore not requiring individual calibrations

7. Microfluidic cartridges should have “filtering” on-board, thereby removing particles larger than the nanoconstriction in order to prevent clogging

8. In the event of a clog, system software shall provide a method for automatically reversing the fluid flow and sending the analyte to waste (so that fresh analyte comes to the nanoconstriction after clearing) in order to clear the clog

9. System particle detection rate should be up to approximately 10,000 particles/sec

In addition to the above, Spectradyne, LLC has exclusive licenses to the following two US patents from The University of California:

• US 8,901,914: High throughput Label Free Nanoparticle Detection and Size Assay

• US 9,945,802: High throughput Label Free Nanoparticle Detection and Size Assay

Finally, Spectradyne owns these patent applications, which are critical to the performance of the instrument and meeting the above specifications:

• PCT/US2016/063421 - Systems and devices for microfluidic cartridge

• PCT/US2016/063411 - Systems and devices for microfluidic instrumentation