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Standardization Cannot Be an Afterthought

For nascent fields like nanoparticle development, data standardization must be a foundational practice.

standardization

Without globally accepted reference materials, the industry is effectively working with a broken ruler, building complex nanoparticle therapeutics on a foundation of unreliable data.

The High Cost of Uncertainty

Advanced therapeutics, from mRNA vaccines to targeted cancer treatments, rely heavily on nanoparticle characterization.

However, the analytical tools we rely on are full of trade-offs, often yielding conflicting results that drive up development costs.

Flawed Conclusions

Incorrect interpretations of nanoparticle data lead to invalid scientific results and wasted research efforts.

Delayed Approvals

Data uncertainty creates bottlenecks, delaying regulatory approval and market entry of novel nanoparticle-enabled therapeutics.

Lost Opportunities

Resources are misdirected from promising innovations to re-evaluate unreliable data and resolve inconsistencies.

Why is Nanoparticle Analysis So Complex?

Because our two main types of analysis techniques tell two completely different stories:
Ensemble Analysis

Measures multiple particles all at once and reports a single result for the entire population.

The "Average" Trap

Because it averages everything, it is blind to complexity and tends to mask critical sub-populations.

"...like looking at a crowd and only guessing the average height."

Single-Particle Analysis

Measures individual particles one-by-one to build high-resolution results.

The "Individual" Trap

High in resolution, but low-level signals are often indistinguishable from background (instrument) noise.

"...like trying to hear a specific whisper in a roaring stadium."

The Takeaway?

Your ensemble analysis might show a single "perfect" 100 nm peak, while completely masking a 40 nm sub-population.

While single-particle analysis can detect this 40 nm population and(!) provide further insights into this sub-population, the signal is typically
close to the instrument's background noise.

 

Without proper controls, you risk measuring artefacts, not your sample!

Beyond the Instruments: The Standardization Gap

Even with the best tools, inconsistency persists due to two fundamental gaps in the industry:
 
Gap 1
REFERENCE MATERIALS
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A Lack of Representative Standards

Most analyzers are calibrated using polystyrene "beads", which are hard, solid, perfect spheres. Calibrations done in this way create a fundamental disconnect when measuring soft, irregular therapeutic nanoparticles with complex surfaces.

This creates a classic apples-to-oranges problem.

Gap 2
DATA CONSISTENCY
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A Lack of Analytical Consistency

User parameters like gain settings, detector thresholds, and gating, distort results by masking sub-populations. Compounding this, each instrument is built on a different physical principle, making meaningful data comparison nearly impossible.

Who is correct? It's difficult to know.

A New Standard for Nanoparticle Analysis

To solve the apples-to-oranges problem, one must first move beyond traditional beads. But what are the alternatives? Commercial standards derived from liposomes or EVs exist, but they are often unstable, inconsistent between batches, and are heterogeneous in both size and morphology.

​​​We specifically engineered Syncles™ to address these trade-offs, delivering the first vesicle standard that is morphologically representative and exceptionally reliable.​

Mimetic Morphology

01

Syncles™ are soft, synthetic vesicles with better morphological resemblance to your real-world samples, unlike hard beads.

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Rock-Solid Reliability

02

Unlike lipid standards, Syncles™ are homogeneous, highly stable without stringent storage conditions, and are exceptionally consistent from lot to lot.

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Versatile Vesicle Palette

03

We offer a large range of Syncles™ with different nanoparticle properties to ensure you have the right standard for your specific application.

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A Universal Benchmark for Your Workflow

Syncles™ serve as a robust common reference material to standardize your process and validate your results, irrespective of whether you're comparing data from day-to-day runs, between different labs, or across different instruments.

Verify Performance
Verify your instrument settings daily to establish a robust baseline for standardizing your datasets over time.
Establish Limitations
Rigorously determine Limit of Detection (LOD), instrument sensitivity, and resolution limits for your specific sample type.
Standardize Collaboration
Anchor different labs to the same Syncles™ standard. Critical for true data comparison and seamless tech transfer to CMOs.

Learn More About Syncles™ 

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Dive Deeper Into the Technicalities

See why results are often inaccurate and how the right standards ensure true validation.

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Explore Syncle™
Products

Ready to find the right standard for your specific application?

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