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Viral vector capsid analytics is critically important to the gene therapy drug sector. Relative to current gold standards in capsid analytics, high resolution ES-DMA provides nearly the same resolution with a benchtop instrument that is much less expensive, faster, and easier to operate.
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Existing gold standards include Cryo-EM, Analytical Ultra Centrifugation (AUC), and the newest: Charge Detection Mass Spectrometry (CD-MS). However, these methods generally require expensive instrumentation and dedicated operators.
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Methods such as light scattering techniques (often combined with other methods such as Size Exclusion Chromatography, UV/Vis or ELISA) and Mass Photometry are less expensive and easier to use, but also less accurate. Most have difficulty resolving capsids that are partially or over filled, and most cannot collect sample after separation for additional testing.
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Only ES-DMA combines excellent accuracy, low cost, ease of use, the ability to detect partial and overilled capsids, and collection after separation. In addition, ES-DMA uses just 1-2 µL of sample per run and requires just 3-5 minutes and no special consumables or reagents. Only ES-DMA can be adapted to at-line testing in production scenarios to support continuous manufacturing of gene therapy drugs.
VS. OTHER NANOPARTICLE SIZERS
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The principle technologies for nanoparticle characterization today are mass spectrometry ("MS") and electron microscopy ("EM"). Both include several variants and feature excellent resolution in their usable size ranges. However, both MS and EM are expensive, and difficult to use without dedicated technicians. These methods require vacuum or freezing, inhibiting the characterization of organic particles in their native state. In addition, EM is not a flow-based instrument, limiting its effectiveness for quantification.
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Many forms of light scattering methods (DLS, MALS, NTA, etc) are also used for biological particle detection and titer analysis. These methods are well established and inexpensive, and can detect particles in the aqueous state. However they are notably low resolution and inaccurate for applications that require particle classification and they are unable to physically separate particles for collection and further testing.
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Ion Mobility Spectrometry ("IMS"), first commercialized in the 1970s, offers a faster, lower cost, and less destructive method to "see" particles in the elusive 1-200 nanometer range. Drift Tube and Traveling Wave IMS have shown good resolutions at the low end of this range but are less accurate for particles >10nm and also cannot separate particles for collection.
Our method, high resolution ES-DMA, is a form of IMS. Recent innovations by Yale's Prof. Juan Fernandez de la Mora, licensed to NanoEngineering Corporation, have increased resolution by an order of magnitude, opening up many new applications in life sciences including viral vector capsid analytics, characterization of protein macromolecules, quality control for vaccine and antibody production and shelf storage, and many other valuable R&D fields. And of course ES-DMA can collect after physical separation, enabling additional testing by means such as PCR, genetic sequencing, tandem DMA, and EM.
ES-DMA offers the best resolution for >20 nm particles where speed, cost and minimal sample disruption are important.
VS. VIRAL DIAGNOSTICS
Today, the main methods to test for viruses are PCR - The "Gold Standard" - and Antigen "Rapid" Test.
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PCR has earned its reputation for accuracy, with approximately 98% sensitivity and 99% specificity in COVID-19 tests. Antigen tests are materially less accurate, with sensitivity of about 80%, meaning one in five tests produce a false negative. Both tests are well established for COVID-19, with many brands currently in production.
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Compared to these tests, ES-DMA has many advantages:
Low Cost
With no reagents and large economies of scale, and no "go-stale" date, ES-DMA virus testing is cost competitive per test. Considering that all viruses can be tested at once, the potential cost advantages are enormous.
No Reagents
Unlike biological tests, ES-DMA is a physics-based test, requiring no expensive virus-specific reagents.
Accessibility
Today's ES-DMA systems from NanoEngineering sit on a benchtop and run on 40W of DC power. Future versions will be smaller, rugged, portable and even easier to operate.
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Tests for all Viruses
Because ES-DMA distinguishes particles by size, it is out-of-the-box "ready" to detect any virus in a sample. One might say ES-DMA is "universally multiplexed."
Speed
ES-DMA tests require 1-2 minutes run-time. NanoEngineering has demonstrated sample prep time of less than one hour, and is currently testing 5-10 minute methods.
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Direct Testing
Unlike PCR and Antigen testing, ES-DMA detects virion capsids directly, counting individual particles, reducing the probabiity of systematic error (e.g. false positives from DNA fragments)
VS. OTHER ES-DMA
NanoEngineering's patented DMA technology offers resolution approaching a full order of magnitude better than commercial systems available today.
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Our systems feature duo-pole electro-spray ionization technology, also licensed from Yale University. Vs. other techniques such as Radio-isotopes and soft x-ray, duo-pole ES is safer, easier to operate, less expensive, and less disruptive to samples.
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Our systems are also more automated and user friendly than any other ES-DMA on the market. NanoEngineering's systems feature programmable control of all major operating parameters, digital camera control of both electro-spray taylor cones, 100% leak-proofing, safety engineering for virus samples.
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